BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2100671 · Received May 17, 2011

    Report

    Report Number
    3004209178-2011-03600
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 28, 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

    IT WAS REPORTED THAT THE PT HAD THEIR LEADS REMOVED FOR PROCEDURE ACCESS WHILE UNDERGOING A REVISION FUSION SURGERY PROCEDURE. A BATTERY PLUG WAS PLACED FOR A LATER REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE NEUROSTIMULATOR WAS REMOVED TO HAVE AN MRI PERFORMED BECAUSE OF NEW PAIN SYMPTOMS POST-FUSION REVISION. THE "MDR" SHOWED HIP LIGAMENT TEARS WHICH WERE CAUSING THIS NEW PAIN. ADDITIONAL INFORMATION WAS 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 56 YR Required Intervention EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA121827N| EXPLANTED:| LEAD: MODEL 3888, LOT# V511853| LEAD: MODEL 3888, LOT# V511853| PROGRAMMER: MODEL 37743, LOT# NKE121381N| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V481207022| EXPLANTED: