BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3213117 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10381
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 30, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PRODUCT WAS PERFORMED. THE DEVICE'S BASIC SENSING AND PACING FUNCTIONS WERE TESTED AND PASSED. THE DEVICE CASE WAS THEN 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 ANOMALY WITH A CAPACITOR WITHIN THE INTEGRATED CIRCUIT. THIS ANOMALY CAUSES A HIGH CURRENT DRAIN, WHICH RESULTED IN PREMATURE BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR LABORATORY TESTING. UPON COMPLETION FROM ANALYSIS, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    A USER FACILITY MEDWATCH WAS ALSO RECEIVED THAT CONTAINED THE SAME INFORMATION THAT WAS PREVIOUSLY REPORTED TO BOSTON SCIENTIFIC.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RECENTLY IMPLANTED PACEMAKER WAS EXHIBITING RAPID BATTERY DEPLETION. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND RETURNED FOR LABORATORY TESTING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OTHER THAN THE EARLY EXPLANT PROCEDURE. THE PATIENT IS NOT PACEMAKER DEPENDENT. THE DEVICE MEMORY WAS REVIEWED BY A BOSTON SCIENTIFIC ENGINEER. THE RAPID BATTERY DEPLETION WAS CONFIRMED. THE DEVICE POWER CONSUMPTION WAS NORMAL PRIOR TO IMPLANT; HOWEVER, ONCE IMPLANTED, THE POWER CONSUMPTION STARTED TO INCREASE DAY BY DAY. THE DAILY VOLTAGE MEASUREMENTS WERE ALSO IRREGULAR WITH ABNORMALLY HIGH MEASUREMENTS. ENGINEERS SUSPECT SOME UNUSUAL EXTERNAL INFLUENCE WAS CONTRIBUTING TO THE RAPID BATTERY DEPLETION. BASED ON THE HIGH CURRENT DRAIN, AN ANOMALY OF THE DEVICE WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313243 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 4076| K173