BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 11054161 · Received December 22, 2020

    Report

    Report Number
    3004209178-2020-22388
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    December 18, 2020
    Report Date
    December 22, 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
    US
    Reporter Occupation
    OTHER

    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 HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THEY ARE TRYING TO PUT INS INTO MRI MODE BUT HAVING DIFFICULTY COMMUNICATING BETWEEN FOB AND INS. CALLER CONSISTENTLY SEEING "NO DEVICE FOUND" ON HANDSET. FOB IS CHARGED UP AND SHOWING BLUETOOTH LIGHTING. MADE MULTIPLE ATTEMPTS TO COMMUNICATE, CALLER AND THE PATIENT PHYSICALLY MOVED TO DIFFERENT AREAS AND ROOMS 3 TIMES BUT THIS DIDN'T RESOLVE THE ISSUE. THE CALLER SHUT DOWN BOTH FOB AND HANDSET, TURN OFF/ON BLUETOOTH BUT THIS DIDN'T RESOLVE. THE CALLER POSITION FOB AT VARIOUS ANGLES AND POSITIONS RELATIVE TO INS BUT THIS DIDN'T RESOLVE. THE PATIENT USED HANDSET AND FOB SUCCESSFULLY YESTERDAY. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522688 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR