BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE RV

    MDR report key: 3993886 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02286
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    September 14, 2000
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND THE INNER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO MIO (METAL ION OXIDATION) WHILE IN VIVO. IT WAS NOTED THAT THE CONNECTOR PIN OF THE LEAD BECAME EXTRINSICALLY DAMAGED DUE TO PULLING/ STRETCHING/ OVERSTRESS. CONCOMITANT PRODUCT: 8960IU ICD, IMPLANTED (B)(6) 1998. F(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FROM THE RIGHT VENTRICULAR (RV) LEAD SECONDARY TO NOISE. THE LEAD WAS CAPPED AND REPLACED. LEAD EXTRACTION WAS ATTEMPTED AT A LATER DATE, HOWEVER, THE LEAD BROKE DURING EXTRACTION AND THE REMAINDER WAS CAPPED AND LEFT IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469476 TRANSVENE RV DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6936-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Hospitalization| L| R 4058M LEAD