BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENAX

    MDR report key: 2123842 · Received June 14, 2011

    Report

    Report Number
    2182208-2011-00723
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 2, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    NONE
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD HAD A WARNING DUE TO HIGH IMPEDANCE AND THE IMPEDANCE REPORT SHOWED THE IMPEDANCE INCREASED AFTER A ROUTINE DEVICE CHANGE OUT. IT WAS ALSO NOTED THAT THERE WAS INTERMITTENT OVERSENSING. THE LEAD REMAINS IN USE AND IS NOW USED FOR SENSING ONLY. 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 77 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR