BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE CS/SVC

    MDR report key: 3993388 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02316
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCOMITANT PRODUCTS: D274TRK ICD IMPLANTED: (B)(6) 2010, LV/IS10 LEAD IMPLANTED: (B)(6) 2006; 672625 ADAPTOR IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEFIBRILLATION THRESHOLD TESTING (DFT) FAILED IN ALL CONFIGURATIONS DURING DEVICE CHANGEOUT. A SUBCUTANEOUS COIL WAS ADDED TO THE SYSTEM AND THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470869 TRANSVENE CS/SVC DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6937A-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R 4470 LEAD, 4513 LEAD, 0154 LEAD