BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRUST VR

    MDR report key: 1854733 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04436
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 14, 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
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. ANALYSIS INDICATES A POWER ON RESET (POR) OCCURRED. A CRITICAL RANDOM ACCESS MEMORY PARITY ERROR WAS RECORDED ON (B)(6) 2010. THE ANALYST COMMENTED THAT THE POR SEVERITY IS LOW. THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET. CORRECTED DATA: PATIENT DATE OF DEATH AND REMOVED DEVICE REMAINS ACTIVATED DEVICE CODE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD A POWER ON RESET (POR) AND WAS IN VVI MODE WHEN INTERROGATED. A SAVE-TO -DISK (S2D) FILE WAS SENT FOR REVIEW. THE DEVICE IS STILL IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRUST VR ASKU LWS MEDTRONIC MED REL, INC. D154VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD