BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2180961 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05662
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 27, 2011
    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
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD MIGRATED SHORTLY AFTER IMPLANT; THEREFORE, THE PT UNDERWENT A LEAD REVISION ON (B)(6) 2011. FOLLOWING THE REVISION, THE LEAD HAD MIGRATED AGAIN. THE LEAD MOVEMENT WAS DETERMINED TO BE OCCIPITAL LEAD MIGRATION. WHILE STIMULATION WAS ON, THE PT EXPERIENCED NUMBNESS IN THE SIDE OF HER FACE AND JAW. THE NEUROSTIMULATOR HAD BEEN TURNED OFF SINCE (B)(6) 2011. THE LEAD IN QUESTION WAS PLACED CERVICALLY FOR MIGRAINES. IT WAS UNCLEAR IF THE PT HAD UNDERGONE A SECOND REVISION. NO PT INJURY OCCURRED.

    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 39 YR Required Intervention PROGRAMMER: MODEL 37743, LOT# NKE161553N| IMPLANTED:| LEAD: MODEL 3778, LOT# V319625014| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA149539N