BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1170826 · Received September 15, 2008

    Report

    Report Number
    3004209178-2008-05739
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    June 1, 2008
    Report Date
    August 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    TWO MONTHS BEFORE THE DATE OF THE COMPLAINT, THE PT WAS ADMITTED TO THE HOSPITAL FOR ABOUT 4-5 DAYS DUE TO CHEST PAIN, DURING WHICH TIME HE HAD A COMPUTERIZED TOMOGRAPHY SCAN AND X-RAYS TAKEN. THE PT WAS UNSURE IF HE HAD A MAGNETIC RESONANCE IMAGING. THE IMPLANTABLE NEUROSTIMULATOR WAS TURNED OFF DURING THE TESTS. SINCE THAT TIME THE PT STIMULATION WAS LOW. HE EVENTUALLY STOPPED FEELING STIMULATION AT ALL. THERE WAS SWELLING AND A WARM FEELING AT THE IMPLANTABLE NEUROSTIMULATOR POCKET. THE PT HAD TROUBLE RECHARGING THE DEVICE. HE COULD CHARGE FOR 3-4 HOURS AND THE BATTERY WOULD BE HALF FULL. THE PT HAD DIFFICULTY SLEEPING; HE WAS ONLY ABLE TO SLEEP FOR 3-4 HOURS AT A TIME. HIS LEGS FELT NUMB. THE PT WAS AT HOME AT THE TIME OF THE REPORT; HIS STATUS WAS REPORTED AS "FAR". THE PT WAS GOING TO F/U WITH HIS HCP. 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 ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR RECHARGER: MODEL 37752| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3777| LEAD: MODEL 37752