BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STIMULATOR

    MDR report key: 2925167 · Received January 22, 2013

    Report

    Report Number
    3007566237-2013-00246
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 3, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S PREVIOUS DEVICE HAD BEEN REJECTED BY THEIR BODY. IT WAS NOTED THERE WAS NO RECORD OF THE PATIENT'S PREVIOUS DEVICE. CALLER REPORTED THE PATIENT HAD THE DEVICE SOMETIME IN 2011 AND FELL ON THEIR RIGHT BUTTOCK AND THE DEVICE WAS 'DESTROYED' AND NEEDED TO BE REPLACED. IT WAS ALSO NOTED THIS DEVICE ERODED AS WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30830 UNKNOWN STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention