BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 3045416 · Received April 9, 2013

    Report

    Report Number
    3004209178-2013-04986
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 2, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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. EVALUATION SUMMARY (B)(4): PERFORMANCE DATA RECEIVED FROM THE DEVICE WAS ANALYZED AND REVEALED POWER ON RESET (CRITICAL RAM PARITY ERROR), WITH 1 - POR FOR CRITICAL RAM PARITY ERROR, PARITY ERROR INDEX COUNT=1, ADDR=1D6B, DATA=0C ON (B)(6) 2012 20:40:03; 1 - PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(6) 2012 20:40:03. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD, (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A PATIENT ALERT DUE TO POWER-ON-RESET (CRITICAL RAM PARITY ERROR). THE DEVICE WAS REPROGRAMMED AND 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
    145437 ENTRUST AT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154ATG

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Required Intervention 6949 IMPLANTABLE DEFIB LEAD