BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENE RV

    MDR report key: 7419048 · Received April 10, 2018

    Report

    Report Number
    2182208-2018-00608
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    May 18, 2017
    Report Date
    April 10, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD IN SEGMENTS WAS RETURNED, ANALYZED AND THE INTERIOR SUPERIOR VENA CAVA DEFIBRILLATION CABLE DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE SETSCREW MARKS ON THE CONNECTOR PIN WERE TOO PROXIMAL. THE INNER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO METAL ION OXIDATION WHILE IN VIVO. CONCOMITANT MEDICAL PRODUCT: 6933110 LEAD IMPLANTED: (B)(6) 1995. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS NOT NEEDED AS THE PATIENT HAD NOT NEEDED THERAPY SINCE 2009. THE RV LEAD WAS EXPLANTED AND RETURNED TO THE MANUFACTURER, ANALYZED, TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262087 TRANSVENE RV DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6936110

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR