BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2190918 · Received July 29, 2011

    Report

    Report Number
    3004209178-2011-05909
    Event Type
    Injury
    Date Received
    July 29, 2011
    Report Date
    July 5, 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

    IT WAS REPORTED THAT THE PT LEAD MIGRATED DOWN. THE LEAD WAS REVISED. THE PT WAS NOTED TO BE "HAPPY" WITH THE RESULTS. IF ADDITIONAL INFO BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SENT.

    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 PROGRAMMER: MODEL 37743, LOT # NKE158896N| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA150262N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT # V663090003