BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRUST AT

    MDR report key: 2964519 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02371
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC DUE TO NOT FEELING WELL. THE DEVICE COULD NOT BE INTERROGATED WITH TWO DIFFERENT PROGRAMMERS. THERE WAS NO ALERT TONE. UNABLE TO OBTAIN FOLLOW UP ON THE SERIAL NUMBER OF THE DEVICE. THE STATUS OF THE DEVICE IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68467 ENTRUST AT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC D154ATG

    Patients

    Seq Age Sex Outcome Treatment
    1