BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGAEBLE NEUROSTIMULATOR

    MDR report key: 1278110 · Received November 24, 2008

    Report

    Report Number
    3004209178-2008-07692
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 24, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS NOT ABLE TO ADJUST THE STIMULATION. REPOSITIONING THE PT PROGRAMMER ANTENNA OVER THE NEUROSTIMULATOR WAS RECOMMENDED. THE DEVICE WAS POWERED OFF. A WEEK AND HALF LATER, THE PT EXPERIENCED INTERMITTENT STIMULATION. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT, HOWEVER, THE PT STATED THE PROBLEMS BEGAN AROUND THE TIME HURRICANE IKE FORCED HIM FROM HIS HOME. THE PT WAS IN GOOD CONDITION AND TEMPORARILY LIVING AT ANOTHER LOCATION. THE PT WAS ENCOURAGED TO CONTACT HIS HEALTH CARE PROFESSIONAL. THE PT HAD BEEN TRAVELING TO THIS HOME ON OCCASION FOR REPAIRS. THE PT REQUESTED PROGRAMMING ASSISTANCE FROM THE MANUFACTURER REPRESENTATIVE. THE PT'S STIMULATOR IS LOCATED IN THE PT'S BACK. THE PT WAS SEEN BY HIS PHYSICIAN. THE STIMULATOR WAS REPROGRAMMED. THE PT WAS ABLE TO RECHARGE SUCCESSFULLY. THE PT WAS NO LONGER HAVING PROBLEMS WITH THE DEVICE SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR PROGRAMMER: MODEL 37742| EXPLANTED:| LEAD: MODEL 3778| LEAD: MODEL 3778| EXPLANTED:| IMPLANTED:| RECHARGER: MODEL 37752| IMPLANTED: