BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2160911 · Received June 16, 2011

    Report

    Report Number
    3004209178-2011-04538
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    January 1, 2008
    Report Date
    May 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN A LOT OF PAIN AND IT FELT LIKE THE WIRES IN HIS BACK WERE "RAKING" AGAINST HIS SPINAL CORD. THE HEALTHCARE PROVIDER (HCP) DID AN X-RAY IN 2008. THE PATIENT STATED THE HCP INDICATED THAT HE HAD 6-8 LOOSE WIRES BUT THAT SHOULD NOT BE A PROBLEM. THE PATIENT WANTED THE DEVICE REMOVED AND HAD BEEN WORKING WITH WORKMAN'S COMPENSATION FOR A RESOLUTION. THE PATIENT WAS IN THE PROCESS OF LOCATING A NEW HCP TO REMOVE THE SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V011953| EXPLANTED:| LEAD: MODEL 3777, LOT# V011891| PROGRAMMER: MODEL 37742, LOT# NJD031557N| IMPLANTED: