BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1852161 · Received September 29, 2010

    Report

    Report Number
    3004209178-2010-07424
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 1, 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
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED STIMULATION IN THE WRONG LOCATION, NO STIMULATION SENSATION, AND A "FADING" SENSATION FOLLOWING REVISION SURGERY WHERE THE LEADS WERE MOVED. THE PT NOTED THAT THE STIMULATION DID NOT WORK AS WELL AS IT DID PRIOR TO THE REVISION SURGERY. THE PT WAS ONLY ABLE TO FEEL STIMULATION WHEN LOOKING UP, OR TO THE LEFT. THE PT STATED THAT STIMULATION USED TO BE FELT WITH THE HEAD IN ANY POSITION. IT WAS FURTHER REPORTED THAT THE STIMULATION TURNED OFF DUE TO THE BATTERY BEING DEPLETED. THE PT EXPERIENCED COUPLING ISSUES WITH THE RECHARGER. THE ANTENNA LOCATE FEATURE WAS USED AND THE PT RECEIVED ALL EIGHT BARS. THE PT REPORTED A BURNING SENSATION AND STATED THAT THIS IS HOW THE REFLEX SYMPATHETIC DYSTROPHY (RSD) PRESENTS IN THIS PT. THE PT WAS TO MEET WITH PHYSICIAN ON (B)(6) 2010. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED BUT NOT RECEIVED AT TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 45 YR EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE146000N| LEAD: MODEL 3778, LOT# V320295002| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA127217N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V341066004| IMPLANTED:| IMPLANTED:| IMPLANTED: