BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRUST

    MDR report key: 4161613 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19031
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    January 20, 2014
    Report Date
    December 10, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-1249-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYSIS OF THE DEVICE MEMORY INDICATES A POWER ON RESET OCCURRED. A CRITICAL POWER ON RESET PARITY ERROR OCCURRED ON (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTRICAL POWER ON RESET HAD OCCURRED ON THE DEVICE. 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
    642040 ENTRUST DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR (B)(4) LEAD, (B)(4) LEAD