BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2905488 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-13542
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 2, 2012
    Report Date
    March 27, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DEVICE BATTERY LONGEVITY MEASURED FIVE (5) YEARS, THEN APPROXIMATELY FIVE MONTHS LATER, DEVICE BATTERY DISPLAYED THREE AND A HALF (3.5) YEARS. FINALLY, APPROXIMATELY EIGHT MONTHS LATER, DEVICE BATTERY LONGEVITY DISPLAYED TWO AND A HALF (2.5) YEARS REMAINING. TO DATE, NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS LATER EXPLANTED FOR NORMAL BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10663 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 4470| 1290| 4471