BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1950571 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23215
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 15, 2010
    Report Date
    January 25, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, A THOROUGH EVALUATION OF THE PRODUCT WAS PERFORMED. THE DEVICE HAD NO TELEMETRY UPON RETURN. ENGINEERING CALCULATIONS CONFIRMED THIS DEVICE LONGEVITY WAS NOT AS EXPECTED. THE DEVICE CASE WAS OPENED. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE DEVICE AND THE ELECTRICAL CURRENT WAS MONITORED. DURING THE MONITORING PROCESS A HIGH CURRENT CONDITION WAS OBSERVED. ELECTRICAL TESTING AND ANALYSIS WERE THEN CONDUCTED, WHICH ISOLATED THE HIGH CURRENT TO AN INTEGRATED CIRCUIT (IC). DETAILED ANALYSIS CONFIRMED THAT THE IC ISSUE CREATED THE HIGH CURRENT CONDITION AND THE REPORTED INABILITY TO INTERROGATE THIS DEVICE.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT, THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED, REPLACED, AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR COULD NOT BE INTERROGATED. A DEVICE MALFUNCTION WAS SUSPECTED. ON (B)(6), 2010 A REVISION PROCEDURE TOOK PLACE AND THERE WAS AGAIN NO INTERROGATION OF THE DEVICE POSSIBLE. DURING THE REVISION THERE WAS NO OBVIOUS CAUSE FOR THE PROBLEM NOTED. THE PHYSICIAN MENTIONED, THAT THE PATIENT DESCRIBED A BEEPING TONE A FEW WEEKS AGO. THE DEVICE WILL BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 Other| R