BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1150245 · Received September 3, 2008

    Report

    Report Number
    3004209178-2008-05401
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT EXPERIENCED A BURNING SENSATION AT THE IMPLANTABLE NEUROSTIMULATOR LOCATION. THE BURNING SENSATION OCCASIONALLY OCCURRED WHEN THE STIMULATOR WAS OFF AND COULD BE RECREATED WITH PALPATION. ALL IMPEDANCE READINGS WERE NORMAL. THERE WAS NO KNOWN INCIDENT OR ACCIDENT RELATED TO THE COMPLAINT. THE PT WAS AT THE CLINIC AT THE TIME OF THE REPORT. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL 37743 LOT# NKE104248N| LEAD MODEL 3778 LOT# V055819021 IMPLANTED:| EXPLANTED:| EXPLANTED:| RECHARGER MODEL 37752 LOT# NKA114766N| LEAD MODEL 3778 LOT# V106506003 IMPLANTED: