BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 2014086 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01599
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    January 14, 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
    IN
    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 PATIENT NOTIFIER ALERTED FOR LOW IMPEDANCE ON (B)(6) 2010 AND THE IMPEDANCE TREND FOR THE RIGHT VENTRICULAR LEAD SHOWED LOW IMPEDANCE VALUES. AFTER PROGRAMMING THE PATIENT'S PULSE GENERATOR TO UNIPOLAR, THE LEAD IMPEDANCE WAS 310 OHMS. LEAD REPLACEMENT WILL BE SCHEDULED.

    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/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR