BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2211078 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-06087
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TELEMETRY ISSUES WERE REPORTED. MULTIPLE PHYSICIAN MODE RECHARGES HAD BEEN DONE AND THE "CALL YOUR DOCTOR" ICON WAS DISPLAYED. THE DEVICE HAD BEEN IN AN OVER-DISCHARGED STATE. A POWER-ON-RESET (POR) CONDITION WAS NOTED. ON (B)(6) 2011 COUPLING ISSUES WERE ALSO NOTED. THE PT HAD RECHARGED ON (B)(6) 2011 FOR FIVE HRS WITH EIGHT COUPLING BARS. THE RECHARGER THEN SHUT OFF, BUT ONLY 25% OF THE NEUROSTIMULATOR BATTERY ICON WAS BLINKING. ON (B)(6) 2011, A POR SCREEN WAS DISPLAYED AS WELL AS A REPOSITION ANTENNA MESSAGE. THE ANTENNA-LOCATE FEATURE RESULTED IN POR MESSAGE FOLLOWED BY THE NORMAL RECHARGING SCREEN; HOWEVER, NO COUPLING BARS WERE ACHIEVED. UPON ADJUSTING THE BELT, 6 COUPLING BARS WERE ACHIEVED. ON (B)(6) 2011, AN INTERROGATION OF THE BATTERY REVEALED IT WAS DISCHARGED AND THE PT WAS INSTRUCTED TO PERFORM A PHYSICIAN MODE RECHARGE, AFTER WHICH A POR CONDITION WAS REPORTED. THE PT HAD TO CHARGE MORE THAN EXPECTED, AND COULD NOT GET THE DEVICE TO CHARGE PAST 50%. THE PT WAS ALSO UNABLE TO ADJUST STIMULATION. THE NEUROSTIMULATOR WAS CHARGED TO 75%, AND A POR WARNING WAS DISPLAYED ON THE PT PROGRAMMER. THE POR WAS CLEARED. ON (B)(6) 2011, THE PT WAS ABLE TO GET HIS DEVICE TO CHARGE; HOWEVER, IT WOULD NOT HOLD A CHARGE DESPITE CHARGING DAILY. REPROGRAMMING WAS ATTEMPTED. IT WAS ALSO NOTED THAT THE LEADS HAD MOVED AND THE PT WAS RECEIVING ABDOMINAL STIMULATION ONLY. THE BATTERY DID NOT APPEAR TO BE AT END-OF-LIFE. THE DEVICE HAD BEEN OVER-DISCHARGED SEVERAL TIMES. THE PT WANTED A NEW SYSTEM IMPLANTED AND POSSIBLY A LEAD REVISION. IT WAS UNK WHETHER A REVISION HAD BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR PROGRAMMER: MODEL 7434, LOT# YN0022773P| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39286-65, LOT# N222011001