BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 2990445 · Received March 5, 2013

    Report

    Report Number
    3007566237-2013-00683
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES, RESULTING IN USING A NEW IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED THAT THE READINGS ON THE ORIGINAL INS WERE GREATER THAN 4,000 OHMS ON SOME OF THE BIPOLARS AS WELL AS THE 0/1, 0/2, 0/3 ELECTRODE COMBINATIONS. A NEW INS WAS USED AND IMPEDANCE READINGS WERE STILL GREATER THAN 4,000 OHMS ON CONTACT 0. THE REPRESENTATIVE STATED THAT "THEY WERE ABLE TO GET A PHYSICAL RESPONSE WHEN THE LEAD WAS TESTED WITH THE J HOOK ON ALL CONTACTS." ONE WEEK LATER IT WAS STATED THAT THE THREE IMPEDANCES SEEN WITH THE NEW INS WERE TESTED IN THE OPERATING ROOM AND THEY SAW A "BELLOWS AND TOE" SO CONTINUED AND IMPLANTED THE PATIENT WITH THE NEW INS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93721 NEU_INS_STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1