BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 2123276 · Received June 14, 2011

    Report

    Report Number
    6000144-2011-02260
    Event Type
    Injury
    Date Received
    June 14, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE DEVICE ANALYSIS IS INCONCLUSIVE AND INCOMPLETE AT THIS TIME. HOWEVER, EXAMINATION OF THE SAVE TO DISK DATA INDICATES THAT A HIGH CURRENT CONDITION EXISTED WHEN THE BATTERY WAS APPROXIMATELY 3.06 VOLTS. THERE WAS NO RECORD OF A POWER ON RESET (POR) PRIOR TO THE INITIAL DIRECT CURRENT DRAIN MEASUREMENT. CURRENT DRAIN IN THE AS RECEIVED CONDITION WAS FOUND TO BE NOMINAL (13 ??A). THE DEVICE WAS MONITORED AND EXAMINED IN VARIOUS MODES IN ATTEMPTS TO INDUCE A HIGH CURRENT CONDITION. A HIGH CURRENT CONDITION WAS NOT OBSERVED DURING EVALUATION OF THE DEVICE.

    Description of Event or Problem · 1

    THE DEVICE WAS REPLACED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. 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 51 YR Other 6949 IMPLANTABLE TACHY LEAD