BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2702553 · Received August 16, 2012

    Report

    Report Number
    3004209178-2012-06969
    Event Type
    Malfunction
    Date Received
    August 16, 2012
    Report Date
    July 18, 2012
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD MODEL 3389S-28, LOT # V199559, IMPLANTED: (B)(6) 2010, EXPLANTED: NA; LEAD MODEL 3389S-28, LOT # V193397, IMPLANTED: (B)(6) 2010, EXPLANTED: NA; EXTENSION MODEL 37085-40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA; EXTENSION MODEL 37085-40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TURNED OFF HER THERAPY FOR AN UNRELATED ABDOMINAL SURGERY. FOLLOWING THE SURGERY, THE PATIENT'S SPOUSE TURNED HER IMPLANT BACK ON, AND SHE VERIFIED IT. THE NEXT DAY, THE PATIENT EXPERIENCED A LOSS OF EFFECT, AND WHEN SHE CHECKED THE IMPLANT SHE FOUND IT WAS OFF. THE PATIENT WAS WONDERING IF EMI COULD HAVE AFFECTED HER IMPLANT OR PATIENT PROGRAMMER. THE PATIENT TURNED THE IMPLANT BACK ON AND HER THERAPY RESUMED. IT WAS REPORTED THAT THE PATIENT WAS FINE.

    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 37601

    Patients

    Seq Age Sex Outcome Treatment
    1