BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1213069 · Received October 23, 2008

    Report

    Report Number
    3004209178-2008-06834
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 25, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A WARM SENSATION AROUND THE IMPLANTABLE NEUROSTIMULATOR POCKET DURING RECHARGING. AFTER AN HOUR AND A HALF OF RECHARGING, THE PATIENT'S SIDE WAS VERY PAINFUL. NO HIGH TEMPERATURE MESSAGE HAD OCCURRED. THE PATIENT CONSULTED WITH THE FIELD REPRESENTATIVE AND WAS GIVEN RECOMMENDATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOME AVAILABLE.

    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 62 YR IMPLNATED:| LEAD: MODEL 3777| EXPLANTED:| RECHARGER: MODEL 37752