BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRUST AT

    MDR report key: 1791810 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03057
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    May 30, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. PREVIOUS EXPERIENCE FROM A RETRO REVIEW FOR DEVICES STILL IN USE HAS BEEN INCORPORATED INTO THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PREVIOUS EXPERIENCE FROM A RETRO REVIEW FOR DEVICES STILL IN USE HAS BEEN INCORPORATED INTO THIS REPORT. 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. CRITICAL RAM PARITY ERRORS CAUSED POWER ON RESET (POR) ON (B)(6) 2008 AND (B)(6) 2010. POR SEVERITY: LOW. THE DEVICE IS EXPECTED TO RECOVER AFTER THIS FAULT TOLERANT BEHAVIOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTRICAL RESET OCCURRED. A PREVIOUS ELECTRICAL RESET OCCURRED IN (B)(6) 2008. THE DEVICE IS STILL 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD