BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE RV

    MDR report key: 3990669 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02229
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNDERSENSING OF R-WAVES HAD BEEN OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS CAPPED AND REPLACED AND THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ALSO REPLACED DURING THE SAME PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468478 TRANSVENE RV DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6936

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R D154VWC DEVICE