BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRUST AT

    MDR report key: 1991624 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00903
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 20, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    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. 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. POWER ON RESET - POWER ON RESET PARAMETERS ONE - POR FOR CRITICAL RAM PARITY ERROR, ADDRESS=1493, DATA=4D ON (B)(6) 2010 16:05:45. ONE - PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(6) 2010 16:05:45. THE DEVICE WAS NOT RETURNED, BUT DIAGNOSTIC INFORMATION IS CONSISTENT WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A POWER-ON RESET. THE DEVICE REMAINS IN USE AND 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD