BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2633234 · Received June 28, 2012

    Report

    Report Number
    3004209178-2012-04909
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Report Date
    May 30, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3389S-40, LOT# V925809, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) SHOWED IMPEDANCE READINGS >4000 OHMS ON ALL BIPOLAR PAIRS AND >2000 OHMS ON ALL UNIPOLAR READINGS. THE INS WAS PLACED ON THE PATIENT'S RIGHT SIDE AND WAS A UNILATERAL LEAD IMPLANT. THE PATIENT'S SYMPTOMS WERE "PRETTY WELL CONTROLLED" EXCEPT FOR SOME MUSCLE TIGHTNESS IN THE LEFT ARM. SWITCHING THE INS FROM BIPOLAR TO UNIPOLAR STIMULATION DID NOT FIX THE ISSUE. THE PATIENT WAS PROGRAMMED TO 2+, 1- AT 1.5 V, 60 US PULSE WIDTH, AND 180 HZ RATE. THE PATIENT'S DOCTOR BELIEVED THE PATIENT WAS GETTING A MICROLESIONING EFFECT AND NOTED THAT THE PATIENT'S MEDICATION HAD BEEN CAUSING DYSKINESIA. X-RAYS WERE GOING TO BE PERFORMED TO COMPARE TO POST-OPERATIVE RECORDS. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1