BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 8646600 · Received May 28, 2019

    Report

    Report Number
    3004209178-2019-10370
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    May 20, 2019
    Report Date
    May 30, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP) 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 REP WAS NOT ABLE TO INCREASE STIMULATION ABOVE 0.0 ON ONE PROGRAM AND ON A SECOND PROGRAM IT COULDN¿T BE INCREASED BEYOND 0.1V. THE REP CHECKED THE LIMIT WHILE ON THE CALL AND THEY HAD IT ON. THE REP WAS ABLE TO INCREASE STIMULATION AFTER REPROGRAMMING THE PATIENT. THE REP REPORTED THEY DIDN¿T SET THE PATIENT THIS WAY AND SUGGESTED THAT IT MIGHT BE BECAUSE THE HEALTHCARE PROVIDER USED A BOVIE. IT WAS REVIEWED THAT THE BOVIE SHOULDN¿T CAUSE SYSTEM LIMITS AND THE CALLER NOTED THEY DIDN¿T HAVE TO RE-ENTER THE SERIAL NUMBER WITH THE CLINICIAN PROGRAMMER WHICH SUGGESTS THAT THE DEVICE DIDN¿T HAVE A POWER-ON-RESET (POR), AND THEY DIDN¿T HAVE TO REPROGRAM THE PATIENT. THE PATIENT WAS ABLE TO INCREASE STIMULATION FURTHER WHEN THE LIMIT WAS OFF. TROUBLESHOOTING RESOLVED THE REPORTED ISSUE. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    THE MANUFACTURER'S REP VIA THE HCP (HEALTHCARE PROFESSIONAL) REPORTED THE PATIENT'S WEIGHT AT THE TIME OF THE EVENT WAS AROUND (B)(6) POUNDS. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438874 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR