BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2771006 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08859
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 6, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7482A51 SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40 LOT# V037049, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATOR WAS INTERROGATED AND WAS SHOWING END OF LIFE/END OF SERVICE MESSAGES. IMPLANTABLE NEUROSTIMULATOR (INS) WAS PROGRAMMED AT 3.0V, 60PW, AND RATE OF 160 WITH C+3- AND OTHER SIDE WAS 3.8V 90 AND 160R AND 4-6+ AND ELECTRODE IMPEDANCE WAS SHOWING 95 ON CONTACTS 4,6. IT WAS REPORTED THAT THE PATIENT HAD SEVERAL FALLS SINCE BEING IMPLANTED IN (B)(6), BUT NOTHING THAT BUMPED HER HEAD. PATIENT WAS GETTING GOOD TREMOR CONTROL UP UNTIL SHE READ THE END OF SERVICE MESSAGE AND EXPERIENCED AN INCREASE IN TREMOR. THIS WAS PREMATURE BATTERY DEPLETION. THE INS WAS REPLACED ON 2012 (B)(6) AND WOULD BE SENT TO THE MANUFACTURER. X-RAY REVEALED THAT THERE WAS NO DISCONNECT OR BROKEN LEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention