BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6196315 · Received December 21, 2016

    Report

    Report Number
    3004209178-2016-27009
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    January 31, 2015
    Report Date
    January 18, 2017
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE INTERSTIM WORKED INITIALLY AFTER IMPLANT AND THEN STOPPED WORKING; PATIENT¿S BLADDER RUNS ALL THE TIME AND HAS TO WEAR PADS. THE PATIENT REPORTED HER KIDNEYS AND BLADDER RUN ALL THE TIME, AND THE INTERSTIM SHOCKED PATIENT ALL THE TIME AND EVEN DECREASING TO THE LOWEST SETTING IT STILL WAS SHOCKING. THE PATIENT THOUGHT THIS WAS BECAUSE HER BLADDER WAS RUNNING ALL THE TIME. THE PATIENT CONFIRMED SHE HAS THERAPY TURNED OFF AND WAS NO LONGER GETTING THE SHOCKING SENSATION. THE PATIENT HAD NOT YET SPOKEN TO MANAGING HEALTH CARE PROVIDER REGARDING THEIR CONCERNS. EVENT STARTED TOWARDS THE END OF (B)(6). THE PATIENT¿S INDICATORS WERE FOR URINARY DYSFUNCTION/SACRAL NERVE STIM /SACRAL NERVE STIM/ GASTROINTESTINAL/ PELVIC FLOOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT AND THE PATIENT REPORTED THAT IT HELPED UNTIL THEIR FIRST OFFICE VISIT. THE PATIENT REPORTED THAT THEIR BLADDER RUNS ALL THE TIME SO THE SHOCK WAS TOO MUCH, TURNED CLEAR DOWN STILL COULD NOT TAKE THE SHOCK AND HAD NOT BEEN TURNED ON SINCE (B)(6) 2015 (THE PATIENT WAS UNSURE OF THE DATE). THE PATIENT REPORTED THAT THE OFFICE VISIT DID NOT CAUSE THIS, THEY JUST TALKED ABOUT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843236 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR