BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1935930 · Received December 3, 2010

    Report

    Report Number
    3004209178-2010-10190
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT NEVER EXPERIENCED THERAPEUTIC EFFECT. THE TRIAL WORKED WELL FOR COVERING HER RIGHT LEG PAIN, BUT DESPITE MULTIPLE REPROGRAMMINGS WITH THE PERMANENT NEUROSTIMULATOR (INS) IT HAS NOT COVERED THE PAIN. HER LEAD HAS MOVED AND NEEDS TO BE REVISED. SHE EXPERIENCED PAIN AT THE INS SITE, BUT IT HAS DECREASED SINCE THE STAPLES WERE REMOVED ON (B)(6) 2010. 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 48 YR ACCESSORY: MODEL 37752, LOT# NKA145755N| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V550377032| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE155551N| EXPLANTED:| LEAD: MODEL 3778, LOT# V550377033