BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1941198 · Received December 22, 2010

    Report

    Report Number
    3004209178-2010-10687
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 9, 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

    THE PT'S NEUROSTIMULATOR (INS) WORKED FOR ONE WEEK, THEN "PROGRAMMED". HIS RIGHT LEAD "FAILED". HE EXPERIENCED GREAT PAIN AND HAS "A FOREIGN OBJECT IN HIS BODY, MY PAIN IS WORSE INSTEAD OF BETTER". ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 42 YR LEAD: MODEL 3777, LOT # V550693010| LEAD: MODEL 3777, LOT # V550693009| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE156181N| ACCESSORY: MODEL 37752, LOT # NKA144112N