BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INS 37604 ACTIVA PC+S NEUROSTIMULATOR

    MDR report key: 4131869 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18065
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ECG EVENTS WERE SEEN IN THE RECORDED BRAIN SENSING DATA. IT WAS NOTED THAT THIS DID NOT IMPACT PATIENT OR PATIENT THERAPY. IT WAS NOTED THAT IT ONLY IMPACTS THE ACCURACY OF THE BRAIN RECORDINGS BEING USED FOR RESEARCH. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE STUDY DEVICES WERE PICKING UP THE PATIENT¿S HEART ACTIVITY IN THE BRAIN RECORDINGS. IT WAS DUE TO LEAKAGE IN THE LEAD/IMPLANTABLE NEUROSTIMULATOR (INS) PORTION OF THE SYSTEM. THE LEAKAGE DID NOT IMPACT STIMULATION THERAPY BUT DID IMPACT THE STUDIES ABILITY TO SEE BRAIN SIGNALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610505 INS 37604 ACTIVA PC+S NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37604

    Patients

    Seq Age Sex Outcome Treatment
    1