BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLETRA

    MDR report key: 2713913 · Received August 24, 2012

    Report

    Report Number
    3004209178-2012-07342
    Event Type
    Death
    Date Received
    August 24, 2012
    Report Date
    July 27, 2012
    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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT# V003964, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT# J0555356V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2012, DUE TO A BRAIN INFECTION. THE PATIENT'S WIFE STATED THAT THIS INFECTION WAS "CAUSED BY THE THERAPY." IT WAS NOTED THAT THE CAUSE OF DEATH WAS DUE TO A "POSSIBLE BRAIN LESION." IT WAS FURTHER NOTED THAT THE PATIENT HAD A BRAIN TUMOR, WHICH WAS CONFIRMED ON (B)(4) 2010, BY A PHYSICIAN. REFER TO MANUFACTURING REPORT # 3004209178-2012-07339.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death SEE H10