BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 1792352 · Received August 11, 2010

    Report

    Report Number
    2182208-2010-00444
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    May 5, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S1
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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: (B)(4) PARTIAL PORTION OF THE LEAD WAS RETURNED TO THE MANUFACTURER IN SEGMENTS. ANALYSIS INDICATED MIDDLE INSULATION BREACHED WITH METAL ION OXIDIATION (MIO). THE DISTAL CONDUCTOR WAS STRETECHED, THE OUTER INSULATION WAS BREACHED MIO AND BLOOD/BODY FLUID WAS NOTED THROUGHOUT THE CONDUCTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAD BEEN 9657 SHORT INTERVAL COUNTS (SIC) SINCE (B)(6) 2010. THERE WERE ALSO 555 NON-SUSTAINED TACHYARRHYTHMIA EPISODES. FURTHER INFORMATION REPORTED HIGH IMPEDANCE, APPARENT LEAD FRACTURE, AND OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN 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 69 YR Required Intervention 7230CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB