BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2934381 · Received January 30, 2013

    Report

    Report Number
    3007566237-2013-00314
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 8, 2013
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD. (B)(4). REPORT SOURCE: CANADA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A LOSS OF STIMULATION IN THE APPROPRIATE AREA. THE PATIENT HAD INITIALLY HAD GOOD RESULTS. THE RE PORTER STATED THAT THE PATIENT FELT A STIMULATION CHANGE AND RETURN OF SYMPTOMS ON (B)(6) 2012 AFTER GETTING IN AND OUT OF A TAXI AND SITTING IN THE TAXI WAS UNCOMFORTABLE. AN IMPEDANCE CHECK SHOWED THE MAJORITY OF CONTACTS WERE GREATER THAN 4000 OHMS. PROGRAMMING WITH THE CONTACTS WITH NORMAL IMPEDANCES DID NOT PROVIDE THE PATIENT WITH SATISFACTORY COVERAGE. IT WAS REPORTED THAT THE PATIENT'S SURGEON HAD SCHEDULED A LEAD REPLACEMENT IN (B)(6). A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40748 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention