BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2120163 · Received June 6, 2011

    Report

    Report Number
    3004209178-2011-04005
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT SEEMED TO BE HAVING AN ALLERGIC REACTION TO SOME PART OF HIS IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM. THE INS AREA WAS RED AND TENDER. A REVISION WAS PERFORMED WHERE THE INS WAS PLACED IN A GORE-TEX POUCH AND REPLACED IN THE SAME POCKET. THE PT WAS DOING WELL FOLLOWING THE REVISION AND THE REDNESS AND TENDERNESS RESOLVED. HE HAD GOOD STIMULATION COVERAGE AND PAIN RELIEF. A FOLLOW-UP 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 62 YR Required Intervention IMPLANTED:| LEAD: MODEL 39565-65, LOT# V655173042| PROGRAMMER: MODEL 37743, LOT# NKE165404N| EXPLANTED:| ACCESSORY: MODEL 37752, NKA150331N