BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE RV

    MDR report key: 4834454 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-01919
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    January 1, 2004
    Report Date
    April 10, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ENCOUNTERED PACING ISSUES. THE RV LEAD PACE/SENSE PORTION WAS DEACTIVATED, AND DEFIBRILLATOR PORTION REMAINED ACTIVE. A IMPLANTABLE PACING LEAD (IPL) WAS IMPLANTED FOR PACE/SENSE FUNCTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376863 TRANSVENE RV DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 693675

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Hospitalization| R ICD