BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENE

    MDR report key: 2811385 · Received October 31, 2012

    Report

    Report Number
    6000023-2012-00030
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC, B.V.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT TRIGGERED, AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCES. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENE IMPLANTABLE TACHY LEAD LWS MEDTRONIC, B.V. 6936

    Patients

    Seq Age Sex Outcome Treatment
    1 Other