BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3911728 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-09049
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    March 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    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 DURING DEVICE CHECK, THIS PACEMAKER HAD BATTERY LONGEVITY OF TWO YEARS REMAINING IN WHICH AFTER FEW MONTHS, WAS FOUND TO BE IN END OF LIFE (EOL) BEHAVIOR. THE PATIENT IS NOT PACEMAKER DEPENDENT HOWEVER THE DEVICE WAS PACING AT 50 PPM IN VVI MODE. LIKEWISE, THE PATIENT WAS ALSO ATRIALLY PACED 80 PERCENT OF THE TIME. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391912 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR MISMATCH| 1286| 4512| 1297| 4012| 1290| 5076| 7006| 4469