BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1852845 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14795
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    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 PATIENT HAS EXPERIENCED SOME SYNCOPAL EPISODES IN THE PAST DUE TO INTERFERENCE WITH HER DEVICE FROM OUTSIDE SOURCES. THE PATIENT IS EXPECTED TO WEAR A BADGE AROUND HER NECK, THAT HAS A BATTERY IN IT, AND IS CONCERNED THAT THE BATTERY WILL INTERFERE WITH HER DEVICE AND CAUSE ADDITIONAL SYNCOPAL EPISODES. THE DEVICE REMAINS IMPLANTED, AND THE PATIENT WILL BE TRYING TO GET PERMISSION TO EITHER NOT WEAR THE BADGE AT ALL, OR WEAR IT SOMEWHERE ON HER BELT. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other 4269| 1298| 4261| 1230