BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2160944 · Received June 16, 2011

    Report

    Report Number
    3004209178-2011-04534
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    January 1, 2009
    Report Date
    May 20, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT INITIALLY HAD GOOD PAIN RELIEF IN HIS HIPS AND LEGS WHILE SITTING AND IN A PRONE POSITION. THE PT HAD 90% OF THE PAIN WHEN HE WALKED OR STOOD UP FOR ANY LENGTH OF TIME. THE PT DEVELOPED A DROPPED LEFT FOOT IN 2009. (B)(6) 2010, THE PT REPORTED PAIN AT THE RIGHT KIDNEY NEAR THE DEVICE. THE PT SUSPECTED THE PAIN WAS DUE TO A KIDNEY STONE. REPROGRAMMING WAS DONE WITH DIFFICULTY "AIMING" THE STIMULATION OR PINPOINTING THE PAIN. THE PT NOTED FEELING THE STIMULATION IN THE WRONG LOCATION. IT WAS SUSPECTED ONLY ONE LEAD WAS WORKING, CROSSED OR HAD "SHORTED OUT." THE PT CHOSE TO MANAGE THE PAIN WITH OVER THE COUNTER PAIN MEDICATION.

    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 IMPLANTED:| LEAD: MODEL 3778, LOT# V156150030| PROGRAMMER: MODEL 37743, LOT# NKE115792N| IMPLANTED:| LEAD: MODEL 3778, LOT# V156150031| ACCESSORY: MODEL 37752, LOT# NKA118273N| EXPLANTED:| EXPLANTED: