BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 2790990 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05518
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    Z-1172-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN ELECTRICAL RESET. THE PATIENT IS UNDERGOING RADIATION THERAPY. THE RESET WAS CLEARED. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRUST AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154ATG

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD