BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1170824 · Received September 15, 2008

    Report

    Report Number
    3004209178-2008-05766
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 19, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD TO RECHARGE HIS DEVICE MORE FREQUENTLY COINCIDING WITH STARTING HEAT RADIOFREQUENCY THERAPY. THE RECHARGING INTERVAL DECREASED FROM ONCE A MONTH TO ONCE A WEEK AND THEN TO ONCE EVERY 3 DAYS. IMPEDANCES WERE FINE. NO PROGRAMMING CHANGES HAD BEEN MADE. THE PT HAD BEEN GETTING GOOD COUPLING AT EVERY RECHARGE. THE DEVICE SETTINGS WERE LOW (NOT SPECIFIED). TECHNICAL SERVICES ESTIMATED THAT THE RECHARGE INTERVAL SHOULD HAVE BEEN ONCE EVERY 3 WEEKS. THE PT WAS IN CONTACT WITH HIS HCP AND MAY STOP USING HEAT RADIOFREQUENCY THERAPY. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES 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 47 YR RECHARGER: MODEL 37752 LOT# UNK| EXTENSION: MODEL 37081 LOT# NJB004364N IMPLANTED| EXPLANTED| EXPLANTED| LEAD: MODEL 3777 LOT# J0564198V IMPLANTED| EXTENSION: MODEL 37081 LOT# NJB003466N IMPLANTED| EXPLANTED| LEAD: MODEL 3777 LOT# J0555082V IMPLANTED| EXPLANTED