BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 1896482 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05064
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    April 9, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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 RIGHT ATRIAL LEAD EXHIBITED LOSS OF CAPTURE, NOISE, P-WAVES COULD NOT BE SENSED AND THERE WAS AN ALERT FOR A LOW LEAD IMPEDANCE OF LESS THAN 100 OHMS ON (B)(6) 2010. THE PATIENT WOULD BE MONITORED.

    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 1882TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR