BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 1072658 · Received July 10, 2008

    Report

    Report Number
    2647346-2008-00366
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 1, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    ASKU

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRUST VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD| UNKNOWN IMPLANTABLE PULSE GENERATOR| 5024M IMPLANTABLE PACING LEAD| 8960IB IMPLANTABLE PULSE GENERATOR