BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3162619 · Received June 11, 2013

    Report

    Report Number
    3007566237-2013-01927
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37713, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED SERIOUS PERSONAL INJURIES FOLLOWING THE FAILURE OF TWO SPINAL STIMULATORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262739 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Other