BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 9245660 · Received October 28, 2019

    Report

    Report Number
    3004209178-2019-20543
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    October 10, 2019
    Report Date
    October 28, 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.

    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 IN THE OPERATING ROOM ALL UNIPOLAR PAIRS WERE SHOWING <(><<)>50 OHMS AND THE BIPOLAR PAIRS WERE SHOWING: 01 1679 OHMS, 02 1625 OHMS, 03 1651 OHMS, 12 1599 OHMS, 13 1599 OHMS, AND 23 1599 OHMS. THE CALLER REPORTED THE PATIENT WAS FEELING MOTOR RESPONSE AT 2V. THE CALLER TURNED OFF ALL LIGHTS, COMPUTERS, AND ANY OTHER EMI SOURCES. THE INS WAS IN THE POCKET AND THE SETSCREW TIGHTENED WHEN THE IMPEDANCES WERE CHECKED. THE CALLER ALSO REPORTED THEY HAD TAKEN OUT THE LEAD AND WIPED IT DOWN 3 TIMES PRIOR TO CALLING. THE CALLER HAD INCREASED THE AMPLITUDE TO 1V, 1.5V, 2V, AND 3V AND THE IMPEDANCE WAS THE SAME. IT WAS SUGGESTED THAT THE CALLER TAKE OUT THE LEAD AND WIPE AGAIN AND CHECK INDIVIDUAL REFERENCE ELECTRODES. THE CALLER STATED THEY WOULD TEST THE LEAD AT 2V AND 330 PULSE WIDTH. THE CALLER ALSO NOTED THEY COULD SEE BELLOWS ON ELECTRODE 1/2 AND ON 1/3 AT 1V. IT WAS NOTED THAT THE PATIENT¿S HANDSET WAS WHAT WAS USED, AND THE OUTCOME WAS MOTOR RESPONSE ON ALL 4 ELECTRODES UNDER 2V. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040707 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR