BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5782205 · Received July 11, 2016

    Report

    Report Number
    3004209178-2016-13894
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    April 1, 2016
    Report Date
    July 11, 2016
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP)REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE WAS SEEN; THERE WAS NO ALLEGATION/DISSATISFACTION REGARDING THE IMPLANTABLE NEUROSTIMULATOR'S (INS) LONGEVITY. THE STIMULATION WAS TURNED BACK ON AND IT WAS NOTED THAT THE PATIENT DID NOT IMMEDIATELY RECEIVE A THERAPEUTIC EFFECT. THE PATIENT ALSO EXPERIENCED A SUDDEN ONSET BODILY SHAKING AND IT "LOOKED LIKE HE WAS SEIZING". IT WAS ALSO REPORTED THAT THE PATIENT USED TO FEEL A "ZING" WHEN HE TURNED THE THERAPY ON, BUT IT HAS SEEN BEEN RESOLVED. THE ISSUES BEGAN OCCURRING 2 MONTHS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436639 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR