BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1911702 · Received November 29, 2010

    Report

    Report Number
    3004209178-2010-09991
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 17, 2010
    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 DEVICE SYSTEM WAS REMOVED DUE TO INFECTION. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP WILL BE SUBMITTED 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 63 YR Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V543664| LEAD: MODEL 3888, LOT# V388292| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB007605V| EXPLANTED:| LEAD: MODEL 3888, LOT# V390153| IMPLANTED:| LEAD: MODEL 3888, LOT# V390153| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB004844V