BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 1072551 · Received July 10, 2008

    Report

    Report Number
    2182208-2008-00244
    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 PERFORMED4, VISUAL EXAMINATION DEVICE PERFORMED ACCORDING TO SPECIFICATIONS NO CONCLUSION CAN BE DRAWN 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. 6933 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7223CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB