BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7740291 · Received August 1, 2018

    Report

    Report Number
    3004209178-2018-17179
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    April 1, 2018
    Report Date
    October 4, 2018
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    3004209178-2018-17179-1 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 THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT PATIENT WAS GETTING POOR COMMUNICATION WITH THE ANTENNA ATTACHED, AND WAS NOT RESOLVED WITH NORMAL TROUBLESHOOTING. PATIENT STATED THEY ALSO STOPPED FEELING STIMULATION AROUND APRIL AND WAS NOT GETTING SYMPTOM CONTROL. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THE CIRCUMSTANCE THAT LED TO THE POOR COMMUNICATION/LOSS OF STIMULATION WAS THAT THEY BELIEVED THE BATTERY WAS NO LONGER FUNCTIONING AFTER 3 YEARS. THE PATIENT STATED THAT THEY TRIED TO PROBLEM SOLVE USING THE BOOK WHICH WAS INCLUDED WITH THE DEVICE BEFORE CONTACTING THE MANUFACTURER. AS A STEP TAKEN TO RESOLVE THE ISSUE, THE PATIENT CONTACTED THE MANUFACTURER'S DEVICE SUPPORT WHERE THEY WERE WALKED THOUGH VARIOUS STEPS TO ATTEMPT ¿REBOOTING¿ THE DEVICE. THE PATIENT WAS TOLD TO CONTACT THEIR DOCTOR¿S OFFICE TO SCHEDULE AN APPOINTMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579967 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR