BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NEUROSTIMULATOR SYSTEM

    MDR report key: 1697528 · Received May 20, 2010

    Report

    Report Number
    MW5016048
    Event Type
    Injury
    Date Received
    May 20, 2010
    Date of Event
    May 16, 2010
    Report Date
    May 20, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    GWF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE INFO CONCERNING THIS EVENT WAS EXTRACTED FROM MULTIPLE DISCUSSIONS WITH THE SUBJECTS TREATING MEDICAL TEAM. THE SUBJECT WAS ADMITTED TO AN ACUTE CARE HOSPITAL ON (B) (6) 2010 AND THE SPONSOR WAS INFORMED OF THE HOSPITALIZATION ON (B) (6) 2010 VIA THE FATHER OF THE SUBJECT. THE SUBJECT WAS ADMITTED DUE TO TACHYCARDIA IN THE 170'S AND OXYGEN SATURATION LEVELS OF 87%. THE SUBJECT WAS NOTED TO HAVE A HIGH GRADE FEVER OF 102.2, BLOOD CULTURES WERE POSITIVE SHOWING GRAM NEGATIVE RODS, AS WELL AS A POSITIVE UA, RAISING THE SUSPICIOUS FOR A REOCCURRENCE OF AN EARLIER TREATED URINARY TRACT INFECTION. THE PT HAS HAD MULTIPLE PRIOR URINE TRACT INFECTIONS THAT HAVE CAUSED PROBLEMS WITH BACTEREMIA. BREATHING TREATMENTS ARE BEING ADMINISTERED PRN AND THE PARTICIPANT REMAINS ON 4L OF OXYGEN. INFECTIOUS DISEASE CONSULT ORDERED AS WELL AS A UROLOGY CONSULT ON (B) (6) 2010. POST UROLOGY CONSULT, THE SUBJECT HAS HAD A NEW FOLEY CATHETER PLACED. IT IS THE OPINION OF DR (B) (6), THE TREATING ATTENDING PHYSICIAN, THAT THIS IS A RECURRENCE OF THE UTI, THAT HAS RESULTED IN BACTEREMIA. THE PT APPEARS TO BE RESPONDING TO ANTIBIOTIC THERAPY FOR HIS UTI AND BACTEREMIA. THERE HAVE BEEN NO CHANGES OR MODIFICATIONS TO THE SUBJECT'S DBS SYSTEM AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC NEUROSTIMULATOR SYSTEM SOLETRA GWF MEDTRONIC 7426 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization