BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENAX

    MDR report key: 3861989 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07099
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 21, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K772203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US 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 VENTRICULAR LEAD EXHIBITED RISING THRESHOLDS. 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
    337986 TENAX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 6962

    Patients

    Seq Age Sex Outcome Treatment
    1 ADSR01 IPG