BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2913749 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00254
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0026-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC FAILURE ANALYSIS ENGINEERS REVIEWED THE DEVICE DATA AND CONFIRMED THAT THE LOW VOLTAGE FAULT CODE WAS VALID; THIS FAULT WAS DECLARED DUE TO AN ACCELERATED DEPLETION OF THE BATTERY. THE CURRENT VOLTAGE WAS NOTED TO BE 2.990 VOLTS, THUS THERAPY DELIVERY WAS UNAFFECTED. BASED ON THE DEVICE'S BATTERY VOLTAGE MEASUREMENTS, THE OVERALL RATE OF DEPLETION APPEARS TO BE CONSTANT. ENGINEERS ESTIMATE THAT THE REMAINING BATTERY CAPACITY (BASED ON THE ACTUAL VOLTAGE LEVEL AND CAPACITY CONSUMED) SHOULD BE SUFFICIENT TO PROVIDE BOTH BRADYCARDIA AND TACHYCARDIA THERAPIES; HOWEVER, A RELIABLE PREDICTION FOR HOW LONG THESE FEATURES CAN BE SUPPORTED CANNOT BE MADE. SINCE IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE (I.E., COMPONENT RESPONSIBLE) FOR THE PREMATURE BATTERY DEPLETION OR PREDICT FUTURE BEHAVIOR OF THE DEVICE BASED SOLELY ON REVIEW OF THE DEVICE MEMORY, BOSTON SCIENTIFIC RECOMMENDS THAT THE DEVICE BE EXPLANTED/REPLACED AND SENT TO OUR QUALITY ASSURANCE LABORATORY FOR DETAILED ANALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS TURNED OFF INSTEAD OF PERFORMING A SURGICAL REVISION DUE TO THE PATIENT'S CONDITION. THE PATIENT WAS RECENTLY PLACED IN HOSPICE CARE DUE TO CANCER.

    Additional Manufacturer Narrative · 1

    A SAVE MEMORY TO DISK IS EXPECTED TO BE RECEIVED IN TS. ONCE ADDITIONAL INFORMATION IS AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING AN OLDER SUBSET OF COGNIS/TELIGEN DEVICES THAT IS MORE SUSCEPTIBLE TO THIS ANOMALY. SPECIFICALLY, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING AN INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS PARTICULAR DEVICE WAS INCLUDED IN THE ADVISORY POPULATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAS BEEN HEARING BEEP TONES COMING FROM THEIR DEVICE OVER THE PAST 2-3 DAYS AND EVERY 6 HOURS. THE PATIENT WAS BROUGHT IN FOR A DEVICE CHECK AND UPON INTERROGATION A FAULT CODE WAS DISPLAYED INDICATING THE BATTERY VOLTAGE HAD DROPPED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND DISCUSSED AN EMERGENT DEVICE REPLACEMENT. AT THIS TIME, THE FIELD REPRESENTATIVE IS NOT AWARE OF WHEN THE DEVICE WOULD BE REPLACED, HOWEVER, REQUESTED THE DEVICE MEMORY BE REVIEWED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21192 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR E102| 0158