BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNWON IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2922637 · Received January 18, 2013

    Report

    Report Number
    3007566237-2013-00231
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    December 31, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S DEVICE WAS FLIPPED WHEN SHE "LOST A LOT OF WEIGHT YEARS AGO." THE REPORTER STATED THAT IT WAS "PROBABLY LONGER THAN FOUR YEARS AGO." IT WAS REPORTED THAT THE DEVICE WAS "MOVED TO THE OTHER SIDE." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27989 UNKNWON IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention