BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3040644 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00857
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 19, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. TELEMETRY COULD NOT BE ESTABLISHED WITH THE DEVICE; HOWEVER, A COPY OF THE DEVICE MEMORY HAD BEEN PREPARED AND REVIEWED PRIOR TO EXPLANT. EXTERNAL VISUAL INSPECTION OF THE DEVICE REVEALED NO ANOMALIES. 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 (CONFIRMED VIA REVIEW OF THE DEVICE MEMORY) 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.

    Additional Manufacturer Narrative · 1

    FOLLOWING RECEIPT OF NEW INFORMATION, THIS EVENT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, THE PATIENT RETURNED AND THE DEVICE WAS EXPLANTED. REPLACEMENT WAS REPORTED SUCCESSFUL WITH ANOTHER BOSTON SCIENTIFIC DEVICE AND THE EXPLANTED UNIT IS INTENDED TO BE RETURNED FOR A POST MARKET PERFORMANCE EVALUATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT SOUGHT MEDICAL ATTENTION DUE TO DEVICE TONES. DURING INTERROGATION A FAULT CODE INDICATING THE VOLTAGE WAS TOO LOW BASED ON THE LIFETIME REMAINING CAPACITY WAS OBSERVED. ALL SYSTEM PARAMETERS WERE THEN CONFIRMED WITHIN NORMAL RANGES AND THE REMAINING CAPACITY WAS NOTED AT HIGHER THAN 8.5 YEARS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE DATA WAS LATER REVIEWED BY BOSTON SCIENTIFIC'S TECHNICAL SERVICE FOR TROUBLESHOOTING ASSISTANCE. ENGINEERING ASSESSMENT CONFIRMED THE DEVICE IS MALFUNCTIONING WITH THE RECOMMENDATION THE PATIENT RETURN FOR PRODUCT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143562 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1