St. Jude Medical Tendril MRI LPA1200M Bedienungsanleitung

Tendril MRI™

Pacing leads

Model LPA1200M

User's Manual

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the

Stat

e of California to cause cancer and birth defects or other reproductive harm. For more information, go to

www.P65Warnings.ca.gov.

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St.

Jude Medical or one of

its subsidiari

es. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St.

Jude

Medical, LLC and its related companies.

Pat.

http://patents.sjm.com

Description

The Tendril MRI™lead, Model LPA1200M, is an MR Conditional, bipolar, steroid-eluting, active

fixation implantable lead with Optim™insulation. The Tendril MRI lead is designed for long-term

pacing and sensing in either the right atrium or right ventricle. The Tendril MRI lead has two

conductors: one terminating at the tip helix and the other at the ring electrode.

The minimum recommended introducer size is 8 French without a retained guidewire and

10.5 French with a retained guidewire.

Features of the Tendril MRI lead include:

Soft tip header — reduces lead tip pressure

Optim insulation — a silicone-polyurethane copolymer

Marker ring — to facilitate optimal lead positioning

Active fixation — features a rotating, extendable/retractable helix for secure anchoring

Steroid elution — the target dose of dexamethasone sodium phosphate (DSP) in the

monolithic controlled release device (MCRD) is 460 micrograms

For information on the specifications of any of these lead models, refer to Technical Specifications

(page 31).

Indications and Usage

The Tendril MRI™lead is a 7.9 French, transvenous, steroid eluting, bipolar, IS-1 compliant,

active fixation lead designed for permanent sensing and pacing in either the right atrium or the

right ventricle, in combination with a compatible device. Active leads such as the Tendril MRI lead

may be indicated for patients where permanent fixation of a passive lead is suspected to be

unstable.

In atrial applications, the use of screw-in leads such as Tendril MRI lead may be indicated in the

presence of an abnormal, surgically altered or excised atrial appendage.

Contraindications

The Tendril MRI™lead is contraindicated:

in the presence of tricuspid atresia

for patients with mechanical tricuspid valves

in patients who are expected to be hypersensitive to a single dose of one milligram of

dexamethasone sodium phosphate.

MR Conditional System

The St. Jude Medical™MR Conditional lead is part of the St. Jude Medical MR Conditional

system.

Patients with an implanted St. Jude Medical MR Conditional system can have an MRI scan if the

conditions for use, as described in the MRI-Ready Systems Manual, are met.

Warnings and Precautions

Implanted cardiac leads are subjected to a hostile environment within the body due to

constant, complex flexural and torsional forces, interactions with leads and/or the device, or

other forces associated with cardiac contractions and patient physical activity, posture and

anatomical influences. Cardiac leads' functional lifetimes can be affected by these and other

factors.

Patients with implanted leads should avoid diathermy, even if the device is programmed off,

as it may damage tissue around the implanted electrodes or may permanently damage the

implantable device system.

Carefully remove the tip retainer from the lead prior to implantation.

For single use only.

Testing has demonstrated that the St. Jude Medical™MR Conditional system is

MR Conditional. A patient with this system may be safely scanned under the conditions

given in the MRI-Ready Systems Manual. Scanning under other conditions may result in

severe patient injury or death. The St. Jude Medical MR Conditional system includes a

St. Jude Medical MR Conditional pulse generator connected to one or more St. Jude Medical

MR Conditional leads.

Storage and Handling

Do not stretch, crush, kink or bend the lead. Leads may be damaged by improper handling

before and during implant or by excessive mechanical stress post-implantation.

Do not bring the lead into contact with sharp objects that could puncture or otherwise

compromise the insulation.

Handle the lead only with powderless, sterile surgical gloves.

Avoid handling the lead with any surgical tools such as hemostats, clamps or forceps.

Leads have an electrostatic attraction for particulate matter; do not expose them to lint, dust

or other such materials.

Avoid touching or handling the lead tip electrode itself.

Do not immerse the lead body in mineral oil, silicone oil, alcohol, or any liquid other than

sterile saline or injectable fluid.

Do not immerse the tip electrode in any fluid prior to implantation; immersion of the

electrode may cause a small amount of steroid to be prematurely eluted.

Lead Implantation

Before opening the lead package, confirm that the lead is compatible with the device to be

implanted.

Lead implantation should be performed only when proper emergency facilities for

cardioversion and/or defibrillation are available.

The manipulation of any and all hardware while in the vascular system should only be

performed under continuous fluoroscopic monitoring.

During this procedure it is advisable to also have echocardiographic equipment available.

If subclavian venipuncture is used for lead introduction, it is important to insert the lead as

lateral as possible during entry of the lead into the vein.

Do not slide the suture sleeve over the electrode rings. This could result in damage to the

lead.

Failure to use the suture sleeve to secure the lead may result in lead dislodgment or in

damage to the lead's insulation and/or conductor coil.

Pay close attention to the handling of the helix extension/retraction mechanism before and

during implantation.

Adverse Events

The Reported Adverse Events (page 3) summarize the adverse events in the Accent MRI™

Pacemaker and Tendril MRI™Lead Investigational Device Exemption Study (MRI Study). The MRI

study was a prospective, multi-center clinical investigation designed to evaluate the safety and

efficacy of the Accent MRI pacemaker system in a patient population indicated for implant of a

pacemaker within and outside of an MRI environment.

Per the investigational plan, an adverse event was defined as any unfavorable clinical event which

impacts, or has the potential to impact the health or safety of a patient caused by or associated

with a study device or intervention.

Adverse events were classified as complications or observations based on the following definitions:

Complications are defined as adverse events that require invasive intervention (e.g. lead

dislodgment requiring repositioning).

Observations are defined as adverse events that can be managed without invasive

intervention (e.g., oversensing or loss of pacing capture, which is remedied by

reprogramming of the pacemaker).

Other Reported Events are any other clinical event that is submitted by the investigator

which is not caused by or associated with the study device and/or system component(s)

and/or defined as an Adverse Event.

Reported Adverse Events

The tables below list the observations and complications reported from the MRI Study, see

Summary Of Clinical Study (page 9). A total of 168 adverse events have been reported in 139

patients, of which 68 are complications and 100 are observations. None of the adverse events

were adjudicated as related to or caused by the study MRI scans.

In addition, 103 other events were reported in 73 patients. None of these events were adjudicated

as related to or caused by the study MRI scans, the study device, or system components.

Table 1. MRI study adverse events

Event Description

# of

Patients

with

AEs1

(n=920)

% of

Patients

with AEs

#AEs

AE/pt-years

(n=1,535.44

yrs)

Complications (total)

63 6.85% 68 0.044

Bleeding/Hematoma 2 0.22% 2 0.001

Cardiac Perforation 2 0.22% 2 0.001

Cardiac Tamponade 3 0.33% 3 0.002

Decompensated HF

0.11%

0.001

Device Connectivity Issue

0.11%

0.001

Device Migration 1 0.11% 1 0.001

Elevated Pacing Thresholds - RA Lead 2 0.22% 2 0.001

Elevated Pacing Thresholds - RV Lead 1 0.11% 1 0.001

Hemoptysis 1 0.11% 1 0.001

1Some patients experienced more than one event and therefore the number of patients is less than the number of events.

Table 1. MRI study adverse events

Event Description

# of

Patients

with

AEs1

(n=920)

% of

Patients

with AEs

#AEs

AE/pt-years

(n=1,535.44

yrs)

Hemothorax

0.11%

0.001

Infection

0.54%

0.003

Lead dislodgement or migration - RA Lead 24 2.61% 25 0.016

Lead dislodgement or migration - RV Lead 7 0.76% 7 0.005

Lead fracture 1 0.11% 1 0.001

Pacemaker Induced Cardiomyopathy 1 0.11% 1 0.001

Pericardial effusion 2 0.22% 2 0.001

Phrenic nerve/diaphragmatic stimulation 1 0.11% 1 0.001

Pneumothorax 4 0.43% 4 0.003

Pocket site/incision pain lasting greater than 72

hours post implant

2 0.22% 2 0.001

Stenosis of the left subclavian vein 1 0.11% 1 0.001

Thrombo-embolic event 1 0.11% 1 0.001

Twiddler’s Syndrome 1 0.11% 1 0.001

Undersensing - RA Lead 1 0.11% 1 0.001

Wound dehiscence 1 0.11% 1 0.001

Observations (total) 87 9.46% 100 0.065

Atrial Arrhythmia 3 0.33% 3 0.002

Bleeding/Hematoma 9 0.98% 9 0.006

Cellulitis/thrombophlebitis 1 0.11% 1 0.001

Cerebrovascular accident 1 0.11% 1 0.001

Decompensated HF 2 0.22% 2 0.001

Elevated pacing thresholds – RA Lead 3 0.33% 3 0.002

Elevated pacing thresholds – RV Lead 1 0.11% 1 0.001

Excessive rate responsive pacing 1 0.11% 1 0.001

Extracardiac stimulation 1 0.11% 1 0.001

Infection 4 0.43% 4 0.003

Lead dislodgement or migration - RA Lead 3 0.33% 3 0.002

Lead dislodgement or migration - RV Lead 1 0.11% 1 0.001

Loss of Capture - RA Lead 1 0.11% 1 0.001

Loss of Capture - RV Lead 1 0.11% 1 0.001

Mechanical abnormality of pacemaker pocket 1 0.11% 1 0.001

Noise reversion 2 0.22% 2 0.001

Oozing from implant site 1 0.11% 1 0.001

Oversensing - RA Lead 2 0.22% 2 0.001

Table 1. MRI study adverse events

Event Description

# of

Patients

with

AEs1

(n=920)

% of

Patients

with AEs

#AEs

AE/pt-years

(n=1,535.44

yrs)

Pacemaker mediated tachycardia (PMT)

2.17%

0.014

Pain at device site

0.11%

0.001

Pectoral stimulation 1 0.11% 1 0.001

Pericardial effusion 4 0.43% 4 0.003

Pericarditis 3 0.33% 3 0.002

Phrenic nerve/diaphragmatic stimulation 1 0.11% 1 0.001

Pleural effusion 1 0.11% 1 0.001

Pneumothorax 7 0.76% 7 0.005

Pocket site/incision pain lasting greater than 72

hours post implant

5 0.54% 5 0.003

Repetitive Nonreentrant Ventriculoatrial

Synchrony

1 0.11% 2 0.001

Set screw damage 1 0.11% 1 0.001

Tachycardia 1 0.11% 1 0.001

Thrombo-embolic event

0.98%

0.006

Undersensing - RA Lead 2 0.22% 2 0.001

Undersensing - RV Lead 2 0.22% 2 0.001

Undersensing - PG 1 0.11% 1 0.001

Table 2. MRI study events not adjudicated as either observations or complications

ORE Description

# of Patients2

# of Events

Comments

Acute Encephalopathy 1 1 Hospitalized for general weakness, altered

mental status and mild CHF.

Angina 6 7 Patients hospitalized for chest pain;

angioplasty performed in one patient,

angioplasty and stenting performed in one

patient and stent placed in one patient. No

action taken in one patient.

Aortic Valve

Replacement

1 1 Patient had history of aortic stenosis; valve

replaced with no sequelae.

Arrest –

Cardiopulmonary

1 1 Patient brought to ER in full arrest;

cardioverted and intubated. Patient

ultimately expired.

2Some patients experienced more than one event and therefore the number of patients is less than the number of events.

Table 2. MRI study events not adjudicated as either observations or complications

ORE Description

# of Patients2

# of Events

Comments

Arrest – Respiratory 1 2 Patient aspirated on an ice chip and went

into respiratory failure ultimately resulting

in patient death.

Asystole 1 1 Patient suffered an acute MI at home and

expired

Atrial Arrhythmia 24 26 Patients had chronic atrial arrhythmias

prior to device implant or arrhythmias were

not attributed to the study

device/procedure.

Atrial Fibrillation 2 2 Medication adjusted in one patient;

catheter ablation done in one patient.

Atrial Flutter

Medication adjusted

Cerebrovascular

Accident

5 5 The CVA remained unresolved in four

patients, two of whom died as a result of

the CVA. One patient went through

rehabilitation and recovered.

Chest Pain 5 5 Chest pain resolved with no action in three

patients. Medication was adjusted on two

patients one of which had cardiac

catheterization.

Compression Fracture

L2 Vertebral Body

1 1 Patient treated with Kyphoplasty

Decompensated Heart

Failure

9 9 Medications added or adjusted. One

patient died due to multiple comorbidities.

Device Upgraded to

CRT

1 1 Tendril MRI RA lead retained. Patient

remains active in study.

Electromagnetic

Interference

1 1 Event unresolvable; no action was taken.

Elevated Pacing

Thresholds

1 2 Events occurred during initial lead

placement; resolved once final lead

placement was obtained.

Episodic Dizziness 1 1 Event resolved with medications

adjustment.

Fall 2 2 Falls unrelated to device or cardiac issues.

Gastroenteritis 1 1 Patient treated with medication; no

additional sequelae.

Hypotension 2 2 Medications adjusted; no additional

sequelae observed.

Left Arm Swelling 1 1 No DVT; no action required.

Left Shoulder Pain 1 1 Pain unrelated to device/implant; no action

required.

Lumbar Spinal

Stenosis

2 2 Patients surgically treated; unrelated to

device/study procedures.

Table 2. MRI study events not adjudicated as either observations or complications

ORE Description

# of Patients2

# of Events

Comments

Mitral Stenosis 1 1 MVR with single vessel CABG.

Nausea & Generalized

Weakness

1 1 Patient withdrew from study due to other

underlying medical conditions unrelated to

study device/procedures.

Perforated Appendix

With Abscess

1 1 Patient had laparoscopic appendectomy.

Pericardial Effusion 1 1 Effusion occurred five months post system

implant; determined to be unrelated to

study system or procedure.

Pleural Effusion 1 1 Patient hospitalized prior to implant for

bilateral effusions and heart block, and

was implanted with study pacemaker

system during the same admission.

Effusion resolved with right thoracentesis

one day before implant.

Pulmonary Edema 1 1 Noted on chest x-ray; no intervention

required.

Shock/Hypotension 2 2 One patient treated with medication; one

patient expired; death unrelated to

device/study procedures.

Shortness of Breath 2 2 Device was reprogrammed in one patient.

No action taken the other patient.

Syncope 2 2 Device reprogrammed

Thrombocytopenia 1 1 Unresolvable; multiple comorbidities

Thrombo-embolic

Event

2 2 Patients treated with anticoagulants

Ventricular Arrhythmia 9 10 One patient died; the death was

adjudicated as not related to study

device/procedure.

Ventricular

Tachycardia

1 1 No intervention required

Total 78 103

Fifty-six (56) patients enrolled in the MRI study were withdrawn from the study due to death.

Three (3) of the deaths were considered to be peri-operative mortalities (occurred ≤ 30 days post-

implant). There were no deaths classified as related to the pacemaker or lead system. No deaths

were considered or adjudicated to be related to MRI scan exposure.

A summary of the Events committee death classifications is shown in the table below.

Table 3. Events committee classification of patients deaths

Primary Cause

Number of Patients

Cardiac: Arrhythmic 4

Cardiac: Ischemic 1

Cardiac: Pump Failure 4

Cardiac: Unknown 1

Non-Cardiac

Unknown 6

TOTAL 56

Potential Adverse Events

Possible adverse events associated with the system, include, but are not limited to the following:

MRI system adverse events:

Lead electrode heating and tissue damage resulting in loss of sensing or capture or both

Lead heating resulting in thrombus formation or embolism

Pulmonary embolism

Device heating resulting in tissue damage in the implant pocket or patient discomfort or both

Induced currents on leads resulting in continuous capture, VT/VF, hemodynamic collapse,

or all three

Damage to the device or leads causing the system to fail to detect or treat irregular

heartbeats or causing the system to treat the patient's condition incorrectly

Damage to the functionality or mechanical integrity of the device resulting in the inability to

communicate with the device

Movement or vibration of the device or leads

Lead dislodgment

Competitive pacing and potential for VT/VF induction if asynchronous pacing is programmed

when MRI Settings are enabled

Syncope due to loss of pacing if no pacing support is programmed with MRI settings

Death due to untreated spontaneous arrhythmia because tachy therapy is disabled when

MRI settings are programmed.

Potential system adverse events:

Air embolism

Body rejection phenomena

Cardiac tamponade or perforation

Hematoma, bleeding hematoma, seroma

Formation of fibrotic tissue; local tissue reaction

Inability to interrogate or program due to programmer or device malfunction

Infection/erosion

Interruption of desired pulse generator function due to electrical interference either

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