BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7876736 · Received September 14, 2018

    Report

    Report Number
    3004209178-2018-20663
    Event Type
    Injury
    Date Received
    September 14, 2018
    Date of Event
    April 1, 2018
    Report Date
    September 14, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THE CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT ¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS ¿WORKING FINE BUT I¿M HAVING OTHER PROBLEMS SO I TURNED THE STIMULATOR OFF BECAUSE I¿M ONLY EMPTYING LIKE 1 TENTH OF MY BLADDER SO I AM CATHETERIZING AGAIN". THE ISSUE STARTED ABOUT 4 MONTHS AGO BUT THEY DID NOT REMEMBER WHICH MONTH. THE PATIENT FURTHER STATED THAT "WE HAD IT TESTED TO SEE IF THE REASON I CAN¿T EMPTY MY BLADDER BUT THEY SAID THE DEVICE IS WORKING PERFECTLY SO I HAD TO START CATHETERIZING, AND THEY TRIED ADJUSTING THE SETTINGS AND EVERYTHING WAS FINE BUT IT CAN¿T HELP MY BLADDER PROBLEM". THE PATIENT INQUIRED IF THE BATTERY WOULD CORRODE OR CAUSE AN INFECTION AND THEY WERE REDIRECTED TO FOLLOW UP WITH THEIR HEALTHCARE PROFESSIONAL (HCP) FOR THE ISSUES. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719950 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other