BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1220440 · Received October 31, 2008

    Report

    Report Number
    3004209178-2008-07090
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THERE WERE NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THE PATIENT WAS SEEN BY THE MANUFACTURER REPRESENTATIVE AT THE CLINIC. CURRENT IMPEDANCE MEASUREMENTS WERE NORMAL. X-RAYS OF THE STIMULATOR / EXTENSION AND LEAD / EXTENSION AREAS WERE RECOMMENDED. THE PATIENT'S STATUS WAS UNDETERMINED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR LEAD: MODEL 3778| PROGRAMMER: MODEL 37742| EXPLANTED:| LEAD: MODEL 3778| EXPLANTED:| IMPLANTED:| IMPLANTED:| RECHARGER: MODEL 37752