BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 2452946 · Received February 15, 2012

    Report

    Report Number
    6000144-2012-00915
    Event Type
    Injury
    Date Received
    February 15, 2012
    Date of Event
    September 20, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    Z-1172-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 PARAMETERS WERE NOTED AS TWO POWER ON RESETS FOR CRITICAL RAM PARITY ERROR, OCCURRED ON (B)(6) 2008 18:18:42 AND (B)(6) 2011 09:02:13. ADDITIONALLY THERE WAS ONE PATIENT ALERT FOR DEVICE CIRCUIT ERROR ON (B)(6) 2011 09:02:13.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN ELECTRICAL RESET. THE DEVICE WAS REPROGRAMMED BY CLEARING THE MESSAGE. THE DEVICE REMAINS 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 VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD