BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1190320 · Received October 6, 2008

    Report

    Report Number
    3004209178-2008-06348
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    January 1, 2006
    Report Date
    September 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE MEDICATION WAS NOT WORKING AND SHE HAD TO STIMULATOR IMPLANTED (2006). SOON AFTER THAT, SHE STARTED HAVING TROUBLE WITH HER RIGHT LEG; IT WAS HURTING AND WEAK. THE IMPLANT WAS IN THE RIGHT BUTTOCK. THE PATIENT DID NOT HAVE PROBLEMS WITH HER LEG IN THE PAST. SHE REQUESTED TO HAVE THE STIMULATOR REMOVED. THE PHYSICIAN TOLD THE PATIENT THAT IT WAS A COINCIDENCE; THE STIMULATOR HAD NOTHING TO DO WITH HER LEG HURTING. HE WAS SURE THAT NO NERVES WERE INJURED. THE PHYSICIAN WANTED TO MOVE THE STIMULATOR TO HER STOMACH. THE PHYSICIAN HAD PUT IN OVER 100 IMPLANTS AND NOT SEEN THIS TROUBLE BEFORE. THE PATIENT STATES SHE FEELS HER BODY MAY BE REJECTING SOMETHING FOREIGN. THE PATIENT HAS BEEN GOING TO A CHIROPRACTOR, PHYSICAL THERAPY, AND HAD THE NERVES TESTED IN HER LEGS. SO FAR, THERE HAS BEEN NOTHING TO EXPLAIN THE PAIN. SHE HAD USED A CANE FOR ABOUT 6 MONTHS. THE PHYSICIAN CONFIRMED THAT THE PATIENT EXPERIENCED RIGHT GLUTEAL PAIN THAT RADIATED DOWN HER LEG; SIMILAR TO SCIATIC NERVE PAIN. THE IMPLANTABLE NEUROSTIMULATOR AND LEAD WERE EXPLANTED. NO SURGICAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention