BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 1791652 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03075
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    December 1, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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) PRELIMINARY ANALYSIS SHOWED THE DEVICE CHARGES BUT DOES NOT DELIVER A CHARGE. UPON FURTHER ANALYSIS, THE NO-DELIVERY CONDITION WAS CONFIRMED AND WAS SHOWN TO BE CAUSED BY A FAULTY TANTALUM CAPACITOR WHICH IS USED TO FILTER AND HOLD THE SUPPLY VOLTAGE FOR AN INTEGRATED CIRCUIT.

    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 50 YR Other 6949 IMPLANTABLE TACHY LEAD