BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 3208940 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-11419
    Event Type
    Death
    Date Received
    July 8, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3387S-40, LOT# V779186, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD, PRODUCT ID: 3387S-40, LOT# V992702, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEATH WAS DUE TO PARKINSON¿S DISEASE PROGRESSION. IT WAS NOTED THAT THE DEATH WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310813 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death