BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST

    MDR report key: 4162568 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19351
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-1249-2012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED, HOWEVER, INFORMATION FROM THE DEVICE MEMORY WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A POWER ON RESET OCCURRED. A PULSED WATCHDOG RESET OCCURRED. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REMOTE MONITORING TRANSMISSION INDICATED THAT AN ELECTRICAL RESET OCCURRED. THE PATIENT REPORTED USING AN OLD POWER SAW AT THE TIME OF THE RESET. THE RESET WAS CLEARED AND THE DEVICE REMAINS 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
    644855 ENTRUST DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention 693165 LEAD