BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2911549 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16256
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 20, 2012
    Report Date
    January 2, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED DATA THAT WAS UPLOADED FROM THE REMOTE MONITORING SYSTEM. TS CONFIRMED THAT AN UNUSUAL DIP IN BATTERY VOLTAGE HAD OCCURRED, HOWEVER THIS DID NOT HAVE AN IMPACT ON THERAPY DELIVERY. SINCE THE DEVICE WAS NOT DETECTING THE LOSS OF BATTERY ENERGY, THE BATTERY STATUS INDICATOR WAS NOT REFLECTING THE DEPLETION CONDITION AND IS INACCURATE. THE RATE OF DEPLETION APPEARED INCONSISTENT OVER TIME. BECAUSE OF THIS, TS RECOMMENDED DEVICE REPLACEMENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY THREE WEEKS LATER THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS ICD WAS THOROUGHLY INSPECTED AND ANALYZED. EXTERNAL VISUAL INSPECTION OF THE DEVICE REVEALED NO ANOMALIES. REVIEW OF THE DEVICE MEMORY CONFIRMED THAT FAULT CODES WERE RECORDED ON (B)(6) 2012. ALTHOUGH THE DEVICE MEMORY DIAGNOSTICS DEMONSTRATED THAT THE DAILY BATTERY VOLTAGE MEASUREMENTS DISPLAYED AN IRREGULAR PATTERN OF DISCHARGE, THE BATTERY VOLTAGE LEVEL AT EXPLANT WAS SUFFICIENT TO ENSURE THERAPY AVAILABILITY/DELIVERY WHILE THE DEVICE WAS IMPLANTED. 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EMITTING BEEP TONES. THE DEVICE WAS CHECKED AND A FAULT CODE INDICATING THE DEVICE'S BATTERY VOLTAGE WAS TOO LOW FOR THE PROJECTED REMAINING CAPACITY WAS OBSERVED UPON DEVICE INTERROGATION. THE PRODUCT REMAINS IN SERVICE AT THIS TIME, HOWEVER A REPLACEMENT IS SCHEDULED IN THE NEXT COUPLE OF WEEKS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16357 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 0185| E102