BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3212412 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08844
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 27, 2013
    Report Date
    November 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PRODUCT WAS PERFORMED. THE DEVICE HAD NO TELEMETRY UPON RETURN. 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 ANOMALY IN AN OXIDE LAYER WITHIN AN INTEGRATED CIRCUIT. THIS ANOMALY CAUSES A HIGH CURRENT DRAIN, WHICH OVER TIME RESULTED IN BATTERY DEPLETION CAUSING THE DEVICE TO BE NONRESPONSIVE TO MAGNET APPLICATION AND INTERROGATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS HOSPITALIZED DUE TO CONGESTIVE HEART FAILURE. UPON INTERROGATION OF THIS SINGLE CHAMBER PACEMAKER WHILE HOSPITALIZED, IT WAS UNABLE TO BE INTERROGATED AND NONRESPONSIVE TO A MAGNET. THE PHYSICIAN SUSPECTED PREMATURE BATTERY DEPLETION FOLLOWING THIS OBSERVATION; ALTHOUGH THE DEVICE WAS ONLY RECENTLY IMPLANTED ONE MONTH AGO. NO OTHER REASON FOR THIS MALFUNCTION WAS OTHERWISE KNOWN. A BOSTON SCIENTIFIC FIELD COMPANY REPRESENTATIVE PERFORMED A DEVICE EVALUATION THE FOLLOWING DAY WITH THE SAME OBSERVATIONS NOTED. A REPLACEMENT PROCEDURE WAS PERFORMED. A NEW PACEMAKER WAS SUCCESSFULLY IMPLANTED AND INTEGRITY OF THE CHRONIC LEAD WAS CONFIRMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED AND ALL FINAL LEAD MEASUREMENTS WERE WITHIN RANGE. THE EXPLANTED PACEMAKER IS BEING RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313974 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND J062

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R