BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1950339 · Received December 14, 2010

    Report

    Report Number
    3004209178-2010-10485
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 2, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING OVER A MONTH AGO THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND MORE BACK PAIN. PT IS HAVING TO TAKE MORE PAIN MEDICATION BECAUSE THE DEVICE IS NOT HELPING. SHE ALSO REPORTS A "STICKING PAIN" AT THE IMPLANT SITE. NO FALLS OR TRAUMA ASSOCIATED WITH THIS COMPLAINT. WHEN THE DEVICE WAS TURNED OFF THE PAIN AT THE IMPLANT SITE SUBSIDED. PT HAD ASKED TO SEE A MEDTRONIC REPRESENTATIVE TO TRY REPROGRAMMING. ADDITIONAL INFORMATION 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 83 YR ACCESSORY: MODEL 37752, LOT# NKA134818N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V370631008| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE139071N| IMPLANTED:| LEAD: MODEL 3777, LOT# V262369025| STIM ACCESSORY: MODEL 3550-39, LOT#N233068