BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3910438 · Received July 2, 2014

    Report

    Report Number
    2124215-2014-07538
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    February 9, 2014
    Report Date
    April 1, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PACEMAKER WAS AT END OF LIFE (EOL) TWO MONTHS AGO. HOWEVER, THIS DEVICE WAS CHECKED 4 MONTHS BEFORE IT REACHED EOL AND IT SHOWED A YEAR REMAINING OF LONGEVITY. THERE WERE NO PROGRAMMING CHANGES DONE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE DEVICE LIKELY WENT TO RETRY WHICH CAUSED GOING TO ERT EARLIER THAN EXPECTED. ATTEMPT TO OBTAIN PERTINENT ADDITIONAL INFORMATION WAS UNSUCCESSFUL. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388318 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR 4469| 1290| 4456