BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 1072552 · Received July 10, 2008

    Report

    Report Number
    2182208-2008-00245
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    January 31, 2005
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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: NO ANOMALIES FOUND; PROXIMAL SEGMENT ANALYZED. MIDDLE INSULATION BREACHED; PROXIMAL SEGMENT ANALYZED. IT WAS REPORTED THE LEADS WERE REPLACED DUE TO INAPPROPRIATE THERAPIES AND SENSING DIFFICULTY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION INSULATION DEGRADATION/DETERIORATION INSULATION DEVICE WAS OUT OF SPECIFICATION IN A MANNER THAT RELATES TO EVENT SENSITIVITY SHOCK, INAPPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEADS WERE REPLACED DUE TO INAPPROPRIATE THERAPIES AND SENSING DIFFICULTY. 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 Required Intervention 7223CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB