BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 1864661 · Received October 12, 2010

    Report

    Report Number
    2182208-2010-00778
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    July 22, 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
    MA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD FRACTURED AND WAS OVERSENSING. THE LEAD WAS CAPPED AND REPLACED. NO 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 72 YR Required Intervention D154VWC IMPLANTABLE PACEMAKER/CARDIO/DEFIB