BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 2377252 · Received December 15, 2011

    Report

    Report Number
    6000144-2011-07767
    Event Type
    Injury
    Date Received
    December 15, 2011
    Date of Event
    September 14, 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
    IN, 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. ONE POWER ON RESET (POR) FOR MEM TEST OCCURRED ON (B)(6) 2011 21:36:00, PARITY BUFFER 1 ADDR=3B80, DATA=27. ONE PATIENT ALERT FOR DEVICE CIRCUIT ERROR OCCURRED ON (B)(6) 2011 21:36:00. DIAGNOSTIC INFORMATION IS CONSISTENT WITH THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE HAD A POWER ON RESET. THE DEVICE WAS RESET AND IS STILL 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD