BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2053631 · Received March 1, 2011

    Report

    Report Number
    3004209178-2011-01529
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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

    RECEIVED INFO THE PT EXPERIENCED A "VIBRATION" THROUGH HIS ENTIRE BODY, FROM HIS NECK TO THE TOES WHILE IN THE HOSPITAL. PT SAID THE SENSATION WAS SIMILAR TO THE NORMAL STIMULATION FROM HIS DEVICE BUT FELT A JOLT WHEN LYING ON THE HOSPITAL BED OR BENDING BACKWARDS WHEN STANDING. THE PT HAD TURNED OFF THE STIMULATION BEFORE ENTERING THE HOSPITAL. A MFR'S REP SAW THE PT IN THE HOSPITAL AND COULD NOT FIND ANY DEVICE PROBLEM. THIS SENSATION LASTED FOR SEVERAL DAYS AFTER THE PT LEFT THE HOSPITAL AND THEN STOPPED. LAST NIGHT WHEN THE PT USED THE CONTROL FOR HIS NEW TEMPURPEDIC BED THE SENSATION BEGAN AGAIN. HE HAD USED THE BED THE NIGHT BEFORE GOING INTO THE HOSPITAL BUT FELT WITH EVERYTHING GOING ON HE MAY NOT HAVE NOTICED THE EFFECT UNTIL HE LAID ON THE HOSPITAL BED. HE IS NOW FEELING THE SENSATION FROM THE NECK, DOWN THE ARMS TO HIS FINGERTIPS. SYSTEM WAS IMPLANTED TO HELP LOW BACK, LEG AND FOOT PAIN. STILL FEELING STIMULATION IN THE CORRECT AREA. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    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 53 YR EXPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE148800N| IMPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA139265N| LEAD: MODEL 3778, LOT # V523346030