BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 8663982 · Received June 3, 2019

    Report

    Report Number
    3004209178-2019-10740
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 1, 2019
    Report Date
    July 16, 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
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS APPROXIMATE. 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

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT FELL 9 FEET OFF OF A ROPE TRAINING AT THE GYM ABOUT A WEEK AGO AND HIT THEIR RIGHT SIDE WHERE THE IMPLANT WAS LOCATED. THE PATIENT STATED AFTER THEIR FALL THEY STOPPED FEELING STIMULATION AND THAT THEY WERE A BIT SORE FROM THE FALL. DURING THE CALL THE PATIENT WAS ABLE TO PULL UP THEIR SETTINGS, THE INS WAS ON AND THE PATIENT FELT STIMULATION COMFORTABLY IN THE BIKE SEAT AREA WHEN THEY INCREASED FROM 1.00 TO 1.30V. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO CHECK THE IMPLANT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER. IN RESPONSE TO THE INQUIRY FOR IF THE PATIENT HAD VISITED THEIR MANAGING PHYSICIAN TO CHECK THEIR IMPLANT AFTER THEIR FALL AND IF A CAUSE HAD BEEN DETERMINED, THE PATIENT REPLIED IN THEIR FIRST LETTER FROM (B)(6) 2019 THAT ¿NO,¿ THEY HAD JUST WANTED TO ADJUST THE INTENSITY AND THEY COULD NOT FOLLOW THE INSTRUCTIONS. THE PATIENT CONTINUED TO STATE ¿TURNS OUT¿ I NEEDED NEW BATTERIES IN THE WAND AND THAT DID THE TRICK.¿ IN THEIR (B)(6) 2019 LETTER, THE PATIENT REPLIED TO THE SAME QUESTION ¿NO,¿ BECAUSE THE PATIENT SERVICES REPRESENTATIVE (REP) ON THE PHONE HELPED THEM RESET THE DEVICE AND THAT EVERYTHING WAS FINE. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456854 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR