BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LEAD

    MDR report key: 2873431 · Received December 14, 2012

    Report

    Report Number
    3007566237-2012-03014
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 21, 2012
    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 A GROUP AT A UNIVERSITY MENTIONED THEY WERE CONCERNED ABOUT TINED LEAD BREAKAGE DURING ITS REMOVAL. IT WAS MENTIONED THAT THE FORCE REQUIRED TO REMOVE THE LEAD WAS VERY CLOSE TO THE FORCE REQUIRED TO BREAK THE LEAD. THE GROUP HAD LEAD BREAKAGE ON "SEVERAL" OCCASIONS. THERE WAS NO PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN LEAD STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1