BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3211022 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07955
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 17, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE CASE WAS OPENED AND INTERNAL VISUAL INSPECTION NOTED NO IRREGULARITIES. AN EXTERNAL POWER SOURCE WAS CONNECTED TO THE DEVICE AND INTERNAL MEASUREMENTS NOTED A HIGH CURRENT DRAIN. FURTHER DETAILED TESTING ISOLATED THE PROBLEM TO A DEGRADED TANTALUM CAPACITOR THAT PREMATURELY DEPLETED THE BATTERY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AFTER THREE MONTHS OF IMPLANT, THIS PACEMAKER DISPLAYED A REMAINING LONGEVITY OF 2.5 YEARS. A LONGEVITY CALCULATION WAS PERFORMED WHICH REVEALED THE REMAINING LONGEVITY WAS SHORTER THAN EXPECTED BASED ON THE PROGRAMMED SETTINGS. AN ANALYSIS OF THE DEVICE MEMORY CONFIRMED AN EXCESS CURRENT DRAW WHICH WAS CAUSING THE BATTERY TO DEPLETE. AN INVASIVE PROCEDURE WAS PERFORMED. THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310958 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R K173| 4469| 4456