BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1884990 · Received October 20, 2010

    Report

    Report Number
    3004209178-2010-08189
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 23, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SITE WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS LOCATED WAS "BOTHERING" THE PT SINCE THE PREVIOUS DAY. THE PT HAD NO FALLS IN APPROX SIX MONTHS. THE PT HAD WALKED "A LOT" THE PREVIOUS DAY WITH FLIP FLOPS INSTEAD OF SNEAKERS, AND ONE OF THE PT'S LEGS IS SHORTER THAN THE OTHER. IT WAS INDICATED THAT THE STIMULATION WAS NOT BOTHERING THE PT, AND THAT THERE WAS NO REDNESS, BRUISING, OR FEVER. THE PT HAD BEEN "RAPED" THE PREVIOUS WEEK AND HAD PAIN DURING THE EXAMINATION AT THE HOSPITAL. THE PT WAS SCHEDULED TO SEE THE HEALTH CARE PROFESSIONAL IN FOUR DAYS. IT WAS REPORTED FIVE DAYS LATER THAT THERE WAS NO STIMULATION SENSATION. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT 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 50 YR EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE139483N| IMPLANTED:| LEAD: MODEL 3778, LOT# V373191031| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V373191030| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA132826N