BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 2604693 · Received June 8, 2012

    Report

    Report Number
    3004209178-2012-04228
    Event Type
    Death
    Date Received
    June 8, 2012
    Date of Event
    February 17, 2012
    Report Date
    May 8, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    EXTENSION MODEL 7482A40 SERIAL# (B)(4) IMPLANTED: (B)(6) 2007 EXPLANTED: UNK; EXTENSION MODEL 748240 SERIAL# (B)(4) IMPLANTED: (B)(6) 2007 EXPLANTED: NA; RECHARGER MODEL 37651 SERIAL# (B)(4); PROGRAMMER MODEL 37642 SERIAL# (B)(4); LEAD MODEL 3387S-40 LOT# V020895 IMPLANTED: (B)(6) 2007 EXPLANTED: UNK; LEAD MODEL 3387S-40 LOT# V020086 IMPLANTED: (B)(6) 2007 EXPLANTED: NA. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S DEATH WAS REPORTED. THE CAUSE OF DEATH WAS NOTED AS TRAUMATIC BRAIN INJURY DUE TO TWO "BAD" FALLS. IT WAS REPORTED THAT THE DEATH WAS NOT RELATED TO THE IMPLANTABLE NEUROSTIMULATOR (INS) ALTHOUGH IT WAS UNCLEAR AS TO ANY ASSOCIATION BETWEEN THE DEVICE AND THE FALLS THAT PRECIPITATED THE PATIENT'S DEATH. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death