BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 2790087 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03306
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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): INNER INSULATION BREACHED, THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), THE INNER INSULATION HAD COSMETIC METAL ION OXIDATION, THE MIDDLE INSULATION HAD COSMETIC METAL ION OXIDATION, THE OUTER INSULATION HAD COSMETIC METAL ION OXIDATION, THE INNER INSULATION WAS BREACHED AND HAD METAL ION OXIDATION, THE MIDDLE INSULATION WAS BREACHED AND HAD METAL ION OXIDATION, THE OUTER INSULATION WAS BREACHED AND HAD METAL ION OXIDATION AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM; PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. FOLLOW-UP DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THIS EVENT. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6933 IMPLANTABLE TACHY LEAD