BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST AT

    MDR report key: 1990178 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00648
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 1, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    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): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. 1 - POR (POWER ON RESET) FOR CRITICAL RAM PARITY ERROR, ADDRESS=0C17, DATA=1A ON (B)(6) 2010 15:36:43. 1 - PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(4) 2010 15:36:43.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET OCCURED. THE DEVICE WAS REPROGRAMMED TO CLEAR THE RESET AND RELOAD FIRMWARE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET OCCURED. THE DEVICE WAS REPROGRAMMED TO CLEAR THE RESET AND RELOAD FIRMWARE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 6945 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 6945 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD