BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 2013950 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01467
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    January 11, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE, CAUSING INAPPROPRIATE MODE SWITCHING. ELECTROGRAM REVIEW INDICATED THAT THE NOISE MAY BE FROM A LEAD FRACTURE OR A CONNECTION ISSUE, SUCH AS A LOOSE SET SCREW. IT WAS ALSO NOTED THAT THE IMPEDANCE WAS CONSISTENTLY GREATER THAN 2000 OHMS, WHICH WOULD INDICATE A LOOSE CONNECTION.

    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/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR