BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3910473 · Received July 2, 2014

    Report

    Report Number
    2124215-2014-09337
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 11, 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). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER BATTERY INDICATOR AS NOT EXPECTED. THE PATIENT WAS SYMPTOMATIC DURING HOSPITAL CHECK AND IT WAS DISCOVERED THAT THE DEVICE REACHED END OF LIFE (EOL). HOWEVER, IT WAS NOTED ON PREVIOUS IN-OFFICE CHECK THAT THIS DEVICE SHOWED 1.5 YEARS REMAINING LONGEVITY AND MAGNET RATE OF 100. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE DEVICE EXHIBITING IN RETRY AT 5.0 VOLTS AND CURRENT BIN HOPPING THAT COULD IMPACT LONGEVITY. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICE AND GAVE IT TO THE PATIENT AS PER REQUEST. THE PACEMAKER WAS REPLACED WITH NEW DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387910 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 4457| 1290| 4470