BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 9603762 · Received January 17, 2020

    Report

    Report Number
    3004209178-2020-01343
    Event Type
    Injury
    Date Received
    January 17, 2020
    Date of Event
    November 20, 2019
    Report Date
    January 17, 2020
    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
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PATIENT HAD THEIR INS AND LEAD REPLACED IN (B)(6) 2019 AND IT¿S NOT WORKING FOR HIM. PATIENT HAD THE HCP (HEALTHCARE PROFESSIONAL) CHECK IT OUT. THEY TURN IT UP A LITTLE BIT, THEN LATER THE PATIENT DOESN'T FEEL THE STIMULATION. PATIENT WILL FEEL THE URGE TO GO. HE URINATES 200-300 CC AT A TIME. HE STOPS AND THINKS HE IS DONE. PATIENT CATHS HIMSELF AND THEN GETS ANOTHER 5-700 CC OUT AFTER HE HAS ALREADY GONE. PATIENT HAS AN APPOINTMENT NEXT MONDAY, (B)(6), WITH THE DOCTOR. PATIENT SAID HE WAS THINKING ABOUT SEEING IF HE CAN GET INTO THE HCP TO SEE IF HIS PROSTATE IS SHUTTING OFF. PATIENT PROVIDED PERTINENT MEDICAL HISTORY: SEVERAL YEARS AGO HE HAD PROSTATE CANCER, HAD OPERATION, AND 45 RADIATION TREATMENTS AND THEY TOLD HIM HE HAS KIDNEY PROBLEMS. PATIENT CALLED BACK LATER AFTER CHARGING EXTERNAL EQUIPMENT AND WAS ABLE TO CONNECT AND ADJUST THE SETTING. PATIENT PLANS TO MONITOR SYMPTOMS FOR ABOUT A DAY AND IF DOESN'T NOTICE ANY IMPROVEMENT TO MAKE ANOTHER ADJUSTMENT AND/OR SWITCH PROGRAM IF NEEDED. PATIENT WEIGHT 210-215 POUNDS. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63339 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention