BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 1050613 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01580
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    July 12, 2007
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. AN X-RAY CONFIRMED LEAD DISLDOGEMENT. THE PATIENT IS PACING LESS THAN 1 PERCENT IN THE ATRIUM AND IS 100 PERCENT BI-VENTRICULAR PACED. THE PHYSICIAN DOES NOT WANT TO REVISE THE ATRIAL LEAD. THE PATIENT WOULD BE MONITORED AT SUBSEQUENT FOLLOW-UP VISTIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1