BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLETRA

    MDR report key: 3100653 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-07403
    Event Type
    Death
    Date Received
    May 8, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V010290, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V010290, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2013. IT WAS NOTED THAT THE CAUSE OF DEATH WAS THAT THE PATIENT HAD CONTRACTED BLOOD CLOTS ALONG WITH HIS PARKINSON'S AND IT CAUSED A STROKE. IT WAS ALSO NOTED THAT THE DEATH WAS NOT RELATED TO THE DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201884 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Death