BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 4140187 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17215
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS BEING SEEN FOR ROUTINE FOLLOW UP. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED. MAGNET APPLICATION WAS UNABLE TO ELICIT TONES. THE PATIENT'S REMOTE HOME MONITORING SYSTEM INDICATED THAT THE DEVICE WAS NOT ABLE TO BE FOUND BY THE SYSTEM. THE PATIENT WAS SUBSEQUENTLY SEEN FOR A CHANGE OUT PROCEDURE WHERE THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WAS RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620088 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E162

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 0295| E162| 4470