BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1853544 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14884
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-1293-06 THRU Z1299-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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'S PHYSICIAN CALLED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) QUESTIONING THE BATTERY REMAINING ON THIS DEVICE. THE BATTERY INDICATOR TWO YEARS AGO STATED BEGINNING OF LIFE, AND NOW SHOWS MUCH LESS THAN THAT. TS SUGGESTED PERFORMING A HEX DUMP AT THE PATIENT'S NEXT VISIT TO GET A MORE ACCURATE BATTERY LONGEVITY ESTIMATE. 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 CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 4086| 1290| 4087