BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 1072896 · Received July 10, 2008

    Report

    Report Number
    2182208-2008-00180
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    March 21, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 - MIDDLE INSULATION SEPARATION. FULL LEAD IN SEGMENTS RETURNED AND ANALYZED. DEFIB CONDUCTOR FRACTURED. NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEADS WERE EXPLANTED DUE TO INFECTION. THEY WERE RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENE IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6936 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 5071 IMPLANTABLE PACING LEAD| 5524M IMPLANTABLE PACING LEAD| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB