BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4152060 · Received October 8, 2014

    Report

    Report Number
    3007566237-2014-02882
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AND SPENT FOUR DAYS IN THE HOSPITAL FOLLOWING A LEAD REPLACEMENT (REFER TO MANUFACTURER¿S REPORT #3007566237-2014-02881 FOR INFORMATION REGARDING THE LEAD REPLACEMENT). THE COLORECTAL NURSE SUSPECTED THE DEVICE WAS NOT SWITCHED OFF PRIOR TO THE SURGERY AND THE DEVICE¿S AMPLITUDE PRIOR TO THE SURGERY ¿RESUMED,¿ CAUSING THE PATIENT PAIN. IT WAS NOTED THE SETTINGS WERE ADJUSTED WITH THE CLINICIAN PROGRAMMER. THE PATIENT RECOVERED AND WAS BACK ON THERAPY. THEY WERE NO LONGER IN PAIN. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632681 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization