BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2923367 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00781
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    April 13, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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): ANALYSIS OF THE NEUROSTIMULATOR MODEL 3058, SERIAL (B)(4) FOUND THAT THE SETSCREW HAD BEEN BACKED OUT TOO FAR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE LEAD STUCK IN THE HEADER BLOCK AND WOULD NOT ADVANCE. THE NEUROSTIMULATOR WAS NOT IMPLANTED AND HAD TO BE REPLACED BECAUSE THEY WERE NOT ABLE TO ADVANCE THE LEAD. THERE WAS NO PATIENT INJURY, AND IT WAS REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31404 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1