BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3840954 · Received May 30, 2014

    Report

    Report Number
    3007566237-2014-01490
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL IMPEDANCES IN THE OPERATING ROOM WERE SHOWING 1700 OHMS OR LESS AND THE PATIENT WAS FEELING STIMULATION IN THE STAGE 2 IMPLANT AFTER THE LEAD WAS ALREADY IN PLACE. IN RECOVERY THE IMPEDANCES WERE GREATER THAN 4000 OHMS ON ALL OF THE BIPOLAR PAIRS AND ON ALL OF THE UNIPOLAR PAIRS. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE RAN THE TEST AT 3V IN RECOVERY BECAUSE THEY HAD ALREADY RUN IT AT 2V AND ALL WERE SHOWING GREATER THAN 4000 OHMS AND AT 3V THERE WAS NO CHANGE. IN THE OPERATING ROOM THE PATIENT WAS FEELING IT AT 1V AND IN RECOVERY THEY WERE NOT FEELING ANYTHING EVEN AT 5.5V. IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE WOULD BE REVIEWING THE INFORMATION WITH THE HEALTH CARE PROVIDER (HCP) TO DISCUSS REVISING. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS EXPLANTED AND A NEW DEVICE WAS IMPLANTED. THE INTERVENTION NEEDED WAS THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) DID NOT SECURE THE LEAD INTO THE BATTERY. IT WAS NOTED THAT THE ACCOUNT WAS RETURNING THE DEVICE AND THE PATIENT OUTCOME OR STATUS WAS THAT THE PATIENT WAS REIMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317838 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention