BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRUST VR

    MDR report key: 1922973 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-06019
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    August 13, 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
    CA, 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. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND INDICATED THAT A POWER ON RESET (POR) OCCURRED ON (B)(6) 2010. THE POR SEVERITY IS LOW. THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET. THE 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 PATIENT'S DEVICE HAD EXPERIENCED AN ELECTRICAL RESET. THE DEVICE REMAINS 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 IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD