BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 3790163 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-06748
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 14, 2014
    Report Date
    May 13, 2014
    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

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

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, AN ENGINEERING-LEVEL LONGEVITY PREDICTION CALCULATION WAS COMPLETED TO ASSESS THE RATE OF BATTERY DEPLETION. THE BATTERY DEPLETED NORMALLY BASED ON THE HIGH ATRIAL OUTPUT OF 5VOLTS (V) WITH PULSE WIDTH OF 1 MILLISECOND (MS) PROGRAMMED TO PROVIDE EFFECTIVE THERAPY TO THE PATIENT. ADDITIONALLY, A SERIES OF DIAGNOSTIC TESTS VERIFIED THE PERFORMANCE OF PACING, SENSING AND RECORDING FUNCTIONS AND WAS FOUND TO FUNCTION NORMALLY.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE CHECK THIS PACEMAKER WAS FOUND TO BE AT END OF LIFE (EOL) IN THE MIDDLE OF MARCH. THE DEVICE WAS VVI50. THE PHYSICIAN WAS CONCERNED SINCE THE PREVIOUS DEVICE CHECK A YEAR AGO THE DEVICE GAS GAUGE WAS HALF WAY AND INDICATED GREATER THAN FIVE YEARS. ADDITIONAL INFORMATION RECEIVED THAT THE DEVICE EXPERIENCED PREMATURE BATTERY DEPLETION (PBD). THE DEVICE WAS EXPLANTED AND WAS REPLACED WITH A NEW ONE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267600 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1294

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 4471| K183| 4470| 1294