BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 1921994 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05837
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 2, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    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 PATIENT NOTED "BURNING" AROUND THE DEVICE AREA, AND UPON APPLYING PRESSURE, A "STINGING" SENSATION WAS EXPERIENCED. IT WAS ALSO REPORTED THAT THIS HAD BEEN OCCURRING INTERMITTENTLY SINCE THE DAY BEFORE. THE PATIENT MENTIONED THAT HE HAS BEEN DOING PHYSICAL LABOR, AND WAS CURRENTLY TRAVELING. THE DEVICE REMAINS IN USE. 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 AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154ATG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other 6942 IMPLANTABLE TACHY LEAD| 4568 IMPLANTABLE PACING LEAD