BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1853484 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14504
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 11, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AND AN UPDATED REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. ALL SEAL PLUGS WERE FOUND INTACT AND THE SETSCREWS MOVED FREELY AND WITHOUT ISSUE. MICROSCOPIC INSPECTION OF EACH PORT FOUND NO ANOMALIES. THE BATTERY VOLTAGE WAS LOWER THAN EXPECTED, BUT STILL SUPPORTED FULL DEVICE FUNCTION. A SERIES OF AUTOMATED ELECTRICAL/FUNCTIONAL TESTS WERE CONDUCTED AND NO ISSUES WITH THE DEVICE¿S ABILITY TO DELIVER THERAPY WERE OBSERVED; BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE WERE VERIFIED. REVIEW OF THE DEVICE MEMORY INDICATED THAT A VOLTAGE ALERT WAS RECORDED. USING HISTORICAL DAILY BATTERY VOLTAGE MEASUREMENT DATA, ENGINEERS DETERMINED THAT THIS DEVICE WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH CURRENT CONDITION ASSOCIATED WITH A COMPROMISED LOW VOLTAGE CAPACITOR CONNECTED TO THE DEVICE¿S BATTERY. LOW VOLTAGE CAPACITORS ARE USED IN THE DEVICE¿S HIGH VOLTAGE CHARGING OPERATION IN ORDER TO FACILITATE FAST CHARGE TIMES. MALFUNCTION OF THESE CAPACITORS RESULTED IN A HIGH CURRENT DRAIN, WHICH WAS DEPLETING THIS DEVICE¿S BATTERY FASTER THAN NORMAL. ON AUGUST 29, 2013, BOSTON SCIENTIFIC DISTRIBUTED A LETTER TO PHYSICIANS CONCERNING THIS ISSUE. THIS LETTER INFORMED PHYSICIANS THAT, IN A SUBSET OF DEVICES, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. LABORATORY ANALYSIS WAS UNABLE TO DETERMINE THE CAUSE OF THE NOISE AND POSSIBLE CONNECTION ISSUE. IT WAS DETERMINED THAT THE DEVICE DID EXPERIENCE A MALFUNCTION OF THE LOW VOLTAGE CAPACITORS. THIS ISSUE WAS REPORTED IN MDR#2124215-2014-12030.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY HAVE CONTRIBUTED TO NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL AND RESULTED IN SURGICAL INTERVENTION TO INVESTIGATE THE ROOT CAUSE. DURING THE REVISION PROCEDURE, THE LEADS WERE REMOVED FROM THE ICD AND TESTED USING A PSA. ALL MEASUREMENTS WERE NORMAL SO THE CHRONIC LEADS WERE REINSERTED AND THE NOISE RESOLVED. IT IS NOT CLEAR WHETHER A LOOSE SET SCREW OR RV LEAD ISSUE (E.G. LEAD WAS NOT FULLY INSERTED) MAY HAVE BEEN THE SOURCE OF THE NOISE. THERE WAS NO ALLEGATION OF MALFUNCTION NOR ANY ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    AT A LATER DATE, THE ICD WAS EXPLANTED FOR AN UNRELATED ISSUE AND WAS RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R