BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 825954 · Received March 9, 2007

    Report

    Report Number
    6000144-2007-00070
    Event Type
    Injury
    Date Received
    March 9, 2007
    Date of Event
    November 10, 2006
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO INAPPROPRIATE SHOCKS CAUSED BY T-WAVE OVERSENSING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 000 Required Intervention