BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1952286 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23823
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 21, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD AND LEAD WERE SUCCESSFULLY REPLACED AND WILL BE RETURNED FOR IMMEDIATE LABORATORY ANALYSIS. ONCE THE PRODUCTS ARE RETURNED AND ANALYSIS COMPLETED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE ICD WAS THOROUGHLY ANALYZED. VISUAL INSPECTION OF THE ICD DISCOVERED AN ARC MARK ON THE BACK SIDE OF THE TITANIUM CASE. REAL TIME X-RAYS OF DEVICE CIRCUITRY REVEALED THAT AN INTERNAL PLASMA FUSE WAS DAMAGED. BOTH TYPES OF DAMAGE ARE INDICATIVE OF A SHORTED LEAD CONDITION DURING SHOCK DELIVERY AND NO OTHER ELECTRICAL TESTING COULD BE CONDUCTED. A REVIEW OF THE DEVICE MEMORY CONFIRMED THAT THE DEVICE HAD THE RECORDED FAULT THAT A SHORT CIRCUIT CONDITION WAS DETECTED DURING SHOCK DELIVERY. IN ADDITION, THE DEVICE ALSO HAD THE RECORDED FAULT OF THE CAPACITOR CHARGE TIME HAS EXCEEDED THE LIMIT. LABORATORY ANALYSIS DETERMINED THAT THE ASSOCIATED LEAD SHORTED TO THE DEVICE CASE DURING SHOCK DELIVERY AND DAMAGED THE PLASMA FUSE WITHIN THE CIRCUITRY. THIS PARTICULAR PORTION CONNECTS THAT CAPACITOR WITH THE BATTERY AND ITS DAMAGE THUS PREVENTED THE CAPACITORS FROM CHARGING. AS A RESULT, THE DEVICE REACHED EOL AFTER THE CHARGE TIME EXCEEDED 45 SECONDS. THE ROOT CAUSE FOR THE DAMAGE ON THIS ICD THAT CAUSED IT TO FAIL WAS INDUCED BY THE COMPROMISED DEFIBRILLATION LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) UNDERWENT A REVISION DUE TO THE DEVICE REACHING END OF LIFE (EOL). DURING THE PROCEDURE, IT WAS DISCOVERED THAT THERE WERE ARC MARKS VISIBLE ON THE DEVICE CASE AS WELL AS ARCING DAMAGE ON THE INSULATION OF THE ASSOCIATED RIGHT VENTRICULAR DEFIBRILLATION LEAD. THE ICD WENT INTO EOL AFTER DELIVERING HIGH VOLTAGE SHOCK THERAPY AND IT IS UNKNOWN IF THE SHOCK DELIVERY WAS EFFECTIVE FOR THE PATIENT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE ICD WAS RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 0181| F102