BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 8480924 · Received April 3, 2019

    Report

    Report Number
    3004209178-2019-06664
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    February 19, 2019
    Report Date
    April 3, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE IS APPROXIMATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL /PELVIC FLOOR THERAPY. IT WAS REPORTED 3 DAYS AGO PATIENT STARTED HAVING HIP PAIN WHERE THE IMPLANT IS, DOWN HER CALF AND LEG MAKING IT HARD TO WALK. SHE REPORTS THERE WAS NUMBNESS AND TINGLING. PATIENT STATES SHE WENT TO AN ORTHOPEDIC HCP AND THEY DID AN ULTRASOUND TO CHECK FOR BLOOD CLOT AND WERE ABLE TO RULE THAT OUT. PATIENT HAS TURNED THE INS OFF BUT IS STILL FEELING THE PAIN IN THE CALF. SHE REPORTS IT IS MORE TOLERABLE WITH IT OFF AND SHE IS ABLE TO WALK. DURING THE CALL PATIENT SERVICES HAD THE PATIENT CONFIRM THE INS WAS OFF WITH THEIR PROGRAMMER; SETTING WAS ON PROGRAM 3 AT 0.65 V. THERE WERE NO TRAUMAS OR FALLS RELATED TO THE ISSUE AND PATIENT STILL HAD PAIN WITH DEVICE OFF. PATIENT REPORTED THIS WAS DAY 4 THAT SHE IS HAVING PAIN (CONFLICTING PREVIOUS TIMELINE) SINCE MARCH 9TH. DURING THE CALL PATIENT ALSO MENTIONED SHE HAS KNEE ISSUE, TORN MENISCUS, KNEE PAIN, BUT CONFIRMED THIS IS UNRELATED TO DEVICE/THERAPY AND IS PRIOR TO IMPLANT. PATIENT ALSO REPORTS SHE HAS HAD 4 ADJUSTMENTS WITH THE STIMULATOR BECAUSE IT WAS NOT WORKING TO PROVIDE THERAPY RELIEF, AND STATES THIS STARTED A FEW WEEKS AGO. PATIENT IS WONDERING IF THE DEVICE IS ON RECALL AND PATIENT SERVICES REVIEWED RECALL INFORMATION WITH THE PATIENT. DUE TO THE PATIENT¿S ALLEGATION OF HAVING PAIN WHEN INS IS ON, PATIENT SERVICES DID NOT TROUBLESHOOT THIS TO SEE IF CHANGING TO A DIFFERENT PROGRAM WOULD PROVIDE RELIEF AND THE PATIENT WAS DIRECTED TO THEIR DOCTOR TO HAVE THE DEVICE CHECKED. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272860 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR