BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 634369 · Received September 9, 2005

    Report

    Report Number
    2017865-2005-00309
    Event Type
    Injury
    Date Received
    September 9, 2005
    Date of Event
    June 13, 2005
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE FIELD DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES THAT ONE WEEK POST IMPLANT, R-WAVES WERE DOWN TO 1.0 MV AND THE CAPTURE THRESHOLD HAD INCREASED TO 4.5 V, 1.5 MV. X-RAY DID NOT REVEAL EVIDENCE OF PERFORATION OR DISLODGMENT. NORMAL FUNCTION ENSUED AFTER THE LEAD WAS REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention