BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY II

    MDR report key: 1852930 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-15380
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Removal / Correction Number
    Z-875/897-03
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACEMAKER WAS UNABLE TO BE INTERROGATED. THIS PATIENT HAS BEEN LOST TO FOLLOW UP AND HAS NOT BEEN SEEN IN YEARS. AT INITIAL INTERROGATION, THE PROGRAMMER RECOGNIZED THE DEVICE BUT COULD NOT COMPETE THE INTERROGATION. BOSTON SCIENTIFIC TECHNICAL SERVICES SUGGESTING TRYING TO PLACE A MAGNET OVER THE DEVICE. THE PATIENT DOES HAVE THEIR OWN INTRINSIC RATE AT 50 BPM. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY II IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1283

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR 4457| 4086| 1283