BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 1862797 · Received October 9, 2010

    Report

    Report Number
    2182208-2010-00766
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    July 21, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S1
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 NO SHOCKS WERE OBSERVED AND LEAD WAS THOROUGHLY TESTED DURING THE DEVICE CHANGE OUT ON (B)(6)2010 AND FOUND TO BE WITHIN NORMAL LIMITS. THE LEAD INTEGRITY ALERT WAS THEN TRIPPED DUE TO OVERSENSING.THE LEAD WAS 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 70 YR Other| R D274 IMPLANTABLE PACEMAKER/CARDIO/DEFIB