BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENAX

    MDR report key: 2123246 · Received June 14, 2011

    Report

    Report Number
    2182208-2011-00712
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    March 1, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    NONE
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 THERE WERE HIGH IMPEDANCE AND OVERSENSING. THE LEAD IS STILL 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 TENAX IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 6917 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other