BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE RV

    MDR report key: 3991257 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02165
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    March 26, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    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 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. PRODUCT EVENT SUMMARY : THE FULL LEAD WAS RETURNED AND ANALYZED; ANALYSIS REVEALED A BREACH OF THE INNER INSULATION DUE TO METAL ION OXIDATION. CONCOMITANT PRODUCT: D154VWC ICD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER NOTED THAT ANOTHER RIGHT VENTRICULAR LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED AND SUBSEQUENTLY 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
    467847 TRANSVENE RV DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6936-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R 6945-65 LEAD