BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESTORE ULTRA

    MDR report key: 1083014 · Received July 28, 2008

    Report

    Report Number
    3004209178-2008-04433
    Event Type
    Death
    Date Received
    July 28, 2008
    Date of Event
    June 28, 2008
    Report Date
    June 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT DIED. SEVERAL DAYS PRIOR, THE PT HAD SEEN THE HCP FOR HER SECOND POST-OP VISIT. NO INFECTION WAS NOTED, JUST POST-OP INCISIONAL PAIN. THE PT HAD REPORTED THE STIMULATION WAS WORKING FOR THE PAIN IN HER ARM AND HAND AND WAS LOOKING FORWARD TO HAVING HER LUMBAR TRIAL. THE PATIENT HAD A HISTORY OF STROKE POST-OP AFTER AN ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) IN THE PAST YEAR. THE SYSTEM HAD NOT BEEN EXPLANTED, AND NO AUTOPSY HAD BEEN PLANNED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death EXPLANTED| IMPLANTED| IMPLANTED| EXTENSION MODEL 37083| EXPLANTED| LEAD MODEL 3986A