BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 2123875 · Received June 14, 2011

    Report

    Report Number
    6000144-2011-02301
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    February 27, 2011
    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. 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 REVEALED THAT POWER ON RESET PARAMETERS (POR) OCCURRED. CRITICAL RAM PARITY ERROR POR WAS RECORDED ON (B)(6) 2011 AT ADDRESS 1A DA. POR SEVERITY: LOW. THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET. THE DEVICE WAS NOT RETURNED, BUT DIAGNOSTIC INFORMATION IS CONSISTENT WITH REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE ENCOUNTERED A POWER ON RESET. THE DEVICE WAS ABLE TO RESET, AND THE LEAD INTEGRITY ALERT SOFTWARE WAS REINSTALLED. 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 VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention (B)(4) IMPLANTABLE TACHY LEAD