BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3306245 · Received August 23, 2013

    Report

    Report Number
    3004209178-2013-15097
    Event Type
    Malfunction
    Date Received
    August 23, 2013
    Report Date
    May 9, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37602, SERIAL# (B)(4); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3387-40, LOT# V051757; PRODUCT TYPE LEAD PRODUCT ID 3387-40, LOT# V040079; PRODUCT TYPE LEAD PRODUCT ID 748251, SERIAL# (B)(4); PRODUCT TYPE EXTENSION PRODUCT ID 748251, SERIAL# (B)(4); PRODUCT TYPE EXTENSION PRODUCT ID 37602, SERIAL# (B)(4); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    REFER TO MANUFACTURER REPORT # 3004209178-2013-15096. IT WAS REPORTED THAT THE PATIENT CURRENT WAS SUDDENLY BEING CARRIED AND A SENSE OF NUMBNESS WAS OFTEN DEVELOPED. THE PATIENT WAS CONCERNED IF THERE WAS ANY POSSIBILITY THAT CURRENT SUDDENLY RISES ON A TEMPORARY BASIS. IT WAS NOTED THAT IT OFTEN HAPPENS WHEN THE PATIENT MOVES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE ERRATIC STIMULATION/NUMBNESS WAS NOT DETERMINED. IT WAS UNKNOWN WHEN THE ISSUE STARTED OCCURRING. NO DEVICE MALFUNCTION DISCOVERED. THE ISSUE HAD NOT BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409981 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR