BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3241579 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12129
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 26, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 748351, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# VA04E7U, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 748351, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40 LOT# VA03LMW, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT, INCLUDING WALKING SIDEWAYS AND CROOKED AND FALLING EVERY OTHER DAY. IT WAS NOTED THAT THE PATIENT WAS NOW DOING PHYSICAL THERAPY AND THE THERAPIST DIDN'T THINK IT WAS VESTIBULAR IN THE EAR. IT WAS NOTED THAT SINCE PHYSICAL THERAPY, THE FALLING HAD GOTTEN BETTER BUT WAS STILL PRESENT. IT WAS REPORTED THAT THE PATIENT¿S VOICE WAS ALSO QUIETER AND LOWER NOW, AND THE INS WAS STILL HELPING HIM SLEEP MORE. IT WAS REPORTED THAT THE PATIENT WAS SITTING ON THE RIGHT SIDE OF A CAR IN THE BACK SIDE WHEN THE CAR WAS REAR ENDED ON THE RIGHT SIDE ON (B)(6) 2013. THE PATIENT HIT HIS HEAD ON SEAT AND WENT TO THE ER SAME DAY AND WAS LOOKED OVER. IT WAS REPORTED THAT THE PATIENT DIDN'T THINK THEY DID ANY X-RAYS BUT THEY CHECKED WITH THE (B)(6) AND SAID EVERYTHING WAS FINE. IT WAS REPORTED THAT THE PATIENT ¿NOSE-DIVED¿ AFTER THAT. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT WITH THE HCP SCHEDULED FOR THE DAY AFTER THE REPORT. 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
    341675 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1