BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 2122459 · Received June 13, 2011

    Report

    Report Number
    6000144-2011-02157
    Event Type
    Injury
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 WAS GIVEN THE REPLACED ICD TO TAKE HOME AND HE "THREW IT AWAY." FOLLOW UP INFORMATION RECEIVED THROUGH CONTACT WITH THE PHYSICIAN OFFICE INDICATED THAT THE DEVICE WAS NOTED TO HAVE "MALFUNCTIONED." THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 73 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD