BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 2451508 · Received February 14, 2012

    Report

    Report Number
    6000144-2012-00768
    Event Type
    Injury
    Date Received
    February 14, 2012
    Date of Event
    June 17, 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
    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. A POR FOR CRITICAL RAM PARITY ERROR, ADDR=1F3D, DATA=F8, OCCURRED ON (B)(4) 2011 03:04:45. A PATIENT ALERT FOR DEVICE CIRCUIT ERROR OCCURRED ON (B)(4) 2011 03:04:45. DIAGNOSTIC INFORMATION IS CONSISTENT WITH THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVICE HAD A POWER ON RESET (POR) OCCUR. AFTER THE POR, THE DEVICE PACED AT VVI70 INSTEAD OF THE STANDARD VVI65. IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN RECEIVING RADIATION THERAPY. THE DEVICE WAS CLEARED, AND 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 55 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD