BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 2533539 · Received April 12, 2012

    Report

    Report Number
    6000144-2012-02574
    Event Type
    Injury
    Date Received
    April 12, 2012
    Date of Event
    February 23, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    Z-1172-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THERE WAS A POWER ON RESET, 1 - POR FOR CRITICAL RAM PARITY ERROR, ADDR=146A DATA=30 ON (B)(4) 2012 03:14:32 AND 1 - PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(4) 2012 03:14:32.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE EXPERIENCED A POWER-ON-RESET DUE TO A DEVICE CIRCUIT 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
    1 ENTRUST AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154ATG

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD