BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3211335 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08132
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC FAILURE ANALYSIS ENGINEERS REVIEWED THE DIAGNOSTIC DATA IN THE DEVICE MEMORY AND CONFIRMED THAT THE LOW VOLTAGE FAULT CODE WAS VALID; THIS FAULT WAS DECLARED ON (B)(6) 2013 DUE TO AN ACCELERATED DEPLETION OF THE BATTERY. NO OTHER FAULTS OR RESETS HAD BEEN STORED WITHIN THE DEVICE MEMORY. 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 WITHIN 7 DAYS AND SENT TO OUR QUALITY ASSURANCE LABORATORY IN (B)(6) FOR DETAILED ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS THOROUGHLY INSPECTED AND ANALYZED. EXTERNAL VISUAL INSPECTION OF THE DEVICE REVEALED NO ANOMALIES. REVIEW OF THE DEVICE MEMORY CONFIRMED THAT FAULT CODE 1003 WAS RECORDED. THE DEVICE CASE WAS THEN OPENED TO FACILITATE ANALYSIS OF THE INTERNAL COMPONENTS. THE BATTERY WAS SEPARATED FROM THE OTHER DEVICE ELECTRONICS AND THE OVERALL CURRENT DRAW OF THE CIRCUITRY WAS MEASURED. A NORMAL CURRENT DRAIN WAS OBSERVED WITHIN THE CIRCUITRY. COLLECTIVELY, THE PATTERN OF IRREGULAR DAILY BATTERY VOLTAGE MEASUREMENTS IN CONJUNCTION WITH NORMAL POWER LEVELS AND DEVICE HYBRID CURRENT DRAW IS CONSISTENT WITH BEHAVIOR OF DEVICES WHERE A LATENT CURRENT LEAKAGE PATH HAS OCCURRED WITHIN THE BATTERY ITSELF, RESULTING IN A PARTIAL DEPLETION OF THE BATTERY. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND RETURNED FOR TESTING. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE YELLOW ALERT WAS GENERATED FOR THIS DEVICE; THE FOLLOWING ERROR MESSAGE (I.E., FAULT CODE 1003) WAS DETECTED: ¿VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY.¿ A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT NOTED THAT APPEARANCE OF FAULT CODE 1003 WAS INDICATIVE OF A BATTERY-RELATED ISSUE WITH THE DEVICE AND, AS SUCH, ADVISED REPLACEMENT OF THE DEVICE. THE TS CONSULTANT ALSO RECOMMENDED PREPARING A COPY OF THE DEVICE MEMORY TO FORWARD TO BOSTON SCIENTIFIC FOR FURTHER ANALYSIS. THIS WOULD ENABLE ENGINEERS TO PROVIDE AN ASSESSMENT OF THE CURRENT DRAIN ON THE DEVICE¿S BATTERY FOR DETERMINING AN APPROPRIATE TIME WINDOW FOR DEVICE REPLACEMENT. A DATA DISK CONTAINING A COPY OF THIS DEVICE¿S MEMORY WAS SUBSEQUENTLY FORWARDED TO BOSTON SCIENTIFIC FOR ENGINEERING REVIEW.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310112 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR E110| 0181| 0158| 4470| T125