BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2223876 · Received August 18, 2011

    Report

    Report Number
    3004209178-2011-06567
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    August 9, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "LEAD WAS POKING A NERVE" AND THE PATIENT WAS NUMB FROM THE WAIST DOWN. THE LEAD WAS REVISED. IT WAS NOTED, THE PATIENT WAS GOING TO HAVE AN ADDITION REVISION SURGERY.

    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 47 YR Required Intervention IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V359496024| PROGRAMMER: MODEL 37743, LOT# NKE135709N| LEAD: MODEL 3778, LOT# V351121023| ACCESSORY: MODEL 37752, LOT# NKA132495N| EXPLANTED: