BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3132403 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08286
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37602, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW, OUT OF RANGE IMPEDANCES WERE MEASURED ON THE PATIENT¿S DEVICE. IT WAS NOTED THAT AN ELECTRODE COMBINATION OF 0 AND 1 WERE MEASURED AT 34 OHMS. IT WAS NOTED THAT C0 WAS 912 OHMS AND C1 WAS 864 OHMS. IT WAS FURTHER NOTED THAT THE PATIENT WAS DIFFICULT TO PROGRAM. . IT WAS FURTHER NOTED THAT THE PATIENT WAS ¿NOT RESPONDING AND STILL FLUCTUATING.¿ IT WAS NOTED THAT THE PATIENT WAS PROGRAMMED ON DOUBLE MONOPOLAR TO CONTROL HER PARKINSON¿S DISEASE AND DYSKINESIA IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING ¿SEVERE PARATHESIA.¿ IT WAS NOTED THAT AN X-RAY WAS PERFORMED AND THE LEAD WAS IN A ¿GOOD¿ POSITION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236930 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1