BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 4132335 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15272
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 19, 2014
    Report Date
    January 21, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE HAD NO OUTPUT AND NO TELEMETRY. VISUAL INSPECTION WAS UNREMARKABLE. 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 HIGHER THAN NORMAL CURRENT DRAIN WAS OBSERVED. ELECTRICAL TESTING AND ANALYSIS OF THE INTERNAL COMPONENTS WERE THEN CONDUCTED, WHICH ISOLATED THE HIGH CURRENT CONDITION TO AN ANOMALY ON ONE OF THE COMPONENT LAYERS (GATE OXIDE) WITHIN THE DEVICE¿S INTEGRATED CIRCUIT. THIS ANOMALY CAUSES A HIGH CURRENT DRAIN, WHICH OVER TIME RESULTS IN PREMATURE BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER COULD NOT BE INTERROGATED. ATTEMPTS TO INTERROGATE THE DEVICE USING DIFFERENT PROGRAMMERS WERE UNSUCCESSFUL. THE DEVICE DID NOT RESPOND TO MAGNET APPLICATION AND AN EKG CONFIRMED THAT THE DEVICE WAS NOT EMITTING ANY PACING PULSES. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612202 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND J063

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4097| 4480| J063