BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2003703 · Received February 24, 2011

    Report

    Report Number
    3004209178-2011-01422
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 1, 2008
    Report Date
    February 8, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REC'D INFO OF A COMPLAINT REGARDING THE USER OF A TITAN ANCHOR DEVICE. THE PT CLAIMS AN ALLEGED UNSPECIFIED INJURY CAUSED BY UNSPECIFIED ISSUES WITH THE DEVICE.

    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 Required Intervention IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB013079N| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3887, LOT# V109266| PROGRAMMER: MODEL 37743, LOT# NKE102766N| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V111112| ACCESSORY: MODEL 37752, LOT# NKA112151N| LEAD: MODEL 3487A, LOT# V111112| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB012744N| IMPLANTED:| LEAD: MODEL 3487A, LOT# V111112