BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1823588 · Received August 27, 2010

    Report

    Report Number
    3004209178-2010-06553
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    May 5, 2009
    Report Date
    July 30, 2010
    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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED IN (B)(6)2009, THAT AFTER THE PATIENT CHARGED THE INS RECHARGER TO ONE-HUNDRED PERCENT, THE DEVICE STILL SHOWED THAT IT NEEDED TO BE CHARGED. THE PATIENT RECEIVED A REPLACEMENT RECHARGER THE FOLLOWING DAY FROM THE MANUFACTURER. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT, FOLLOWING IMPLANTATION. THE PATIENT EXPERIENCED PAIN RELIEF FOR ONLY A FEW DAYS, AFTER EVERY PROGRAMMING SESSION. THE PATIENT FELT PAIN IN THE HIP BONE AND DOWN THE LEG. IT WAS NOT STATED WHAT SIDE HIP AND LEG WERE INVOLVED. THERE WAS NO KNOWN RELATED INCIDENT OR ACCIDENT REPORTED. THE PATIENT WAS SCHEDULED FOR REPROGRAMMING. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED A SURGING SENSATION, WHEN THE STIMULATION WAS TURNED ON. THE PATIENT (FELT A SHOCKING OR JOLTING SENSATION. THE PATIENT STATED THAT THE PROGRAMMER WORKED BETTER WHEN NOT IN THE PATIENT'S APARTMENT BUILDING. THE PATIENT SUGGESTED THAT ENVIRONMENTAL (HOME) INTERFERENCE AFFECTED THE PATIENT PROGRAMMER. THE PATIENT FURTHER REPORTED THAT THE ANTENNA DID NOT STAY PLUGGED INTO THE ANTENNA JACK. IT WAS NOTED THAT THE PATIENT WAS REPROGRAMMED ON TWO OCCASIONS AND HAD ADEQUATE STIMULATION FOR THE PAIN. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WERE PROVIDED AT THE TIME OF THIS REPORT.

    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 64 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT # NHU052762V| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE122506N| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA113816N| LEAD: MODEL 3487A, LOT # J0424776V| EXTENSION: MODEL 7489, LOT # NHU052761V| EXPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA126651N| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT # NFT041334P| EXPLANTED:| LEAD: MODEL 3487A, LOT # J0424776V| IMPLANTED:| EXPLANTED:| EXPLANTED: