BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2955293 · Received February 11, 2013

    Report

    Report Number
    3007566237-2013-00446
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD BROKE DURING EXPLANT, RESULTING IN THE END OF THE LEAD WITH ALL ELECTRODES BEING STILL IMPLANTED IN THE PATIENT. THE REPORTER STATED THAT THEY WERE UNABLE TO BE RETRIEVED AND THE FRAGMENT REMAINED IN THE PATIENT. IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS AND THE PATIENT SUFFERED NO INJURY OR ADVERSE EVENT. TWO WEEKS LATER, IT WAS REPORTED THAT THE LEAD WAS EXPLANTED BECAUSE THE PATIENT DID NOT FEEL THE DEVICE WAS WORKING AND FOR "PSYCHOLOGICAL REASONS" THE PATIENT WANTED THE DEVICE SYSTEM REMOVED. IT WAS NOTED THAT A DEVICE WAS NOT RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58365 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other