BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2031351 · Received March 16, 2011

    Report

    Report Number
    3004209178-2011-01988
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    February 28, 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
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD COUPLING AND OR COMMUNICATION ISSUES WITH THE RECHARGER. THE DEVICE FELT LIKE IT HAD "TWISTED". THE PT USUALLY HAD 3-4 EFFICIENCY BOXES SHADED ON THE RECHARGER WHEN RECHARGING. THE PT WAS ALSO CONCERNED THE BELT WAS SO TIGHT THAT IT PUSHED THE IMPLANT IN. THE PT HAD LAST RECHARGED THE IMPLANTABLE NEUROSTIMULATOR (INS) ABOUT MID (B)(6) 2010, BUT IT WAS NOT FULLY RECHARGED. RECHARGING PROCESS WAS REVIEWED. THE PT SAW THE POOR COMMUNICATION SCREEN ON THE PT PROGRAMMER. THREE AND A HALF MONTHS LATER, RECHARGING PROBLEMS WERE AGAIN REPORTED. IT WAS REPORTED THAT THE PT'S INS WAS "RESET". THE PT WAS THEN ABLE TO GET 8 BARS WHEN CHARGED, WHICH HE NEVER HAD BEFORE. PRIOR TO THAT THE PT COULD ONLY GET 4 BARS AND WOULD HAVE TO PRESS SO HARD, IT HURT. THE PT ALSO REPORTED BEING UNABLE TO TURN THE INS ON. AN OVERDISCHARGE WAS SUSPECTED. THE PT WAS SEEN AND THE DEVICE WAS "RESET". THE PT WAS SEEN BY SOMEONE ELSE LATER AND WAS TOLD THE INS "ONLY HAD 10% LIFE LEFT". THE PT THEN REPORTED STIMULATION IN THE WRONG LOCATION. THE INS WAS IMPLANTED FOR THE PT'S UPPER EXTREMITIES, BUT STIMULATION WAS FELT IN HIS LOWER EXTREMITIES. IT WAS REPORTED THAT THE INS WORKED "PERIODICALLY". IT WAS FURTHER REPORTED THAT THE STIMULATION WAS TURNING OFF AND ON, AND THERE WERE CHANGES IN STIMULATION WITH CHANGES IN POSITION. THE PT WAS SEEN AND IT WAS NOTED THAT THE PT HAD A HARD TIME GETTING A GOOD CONNECTION. THE PT HAD TO LIE ON ONE SIDE TO GET GOOD COUPLING. IT WAS ALSO NOTED THAT 85-95% OF THE INS WAS USED. TWO WEEKS LATER, IT WAS REPORTED THAT THE PT HAD ALWAYS HAD PROBLEMS WITH RECHARGING. IT WAS REPORTED THAT THE BATTERY HAD "NEVER CHARGED RIGHT" AND WAS DETECTIVE. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| LEAD: MODEL 3777, LOT# J0555461V| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD019160N