BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 2240509 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05716
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 22, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE DISTAL INSULATION WAS DAMAGED AT 31.5 CM FROM THE CONNECTOR PIN. THE DAMAGED INSULATION CAUSED A SHORT CIRCUIT, WHICH CAUSED THE LOW LEAD IMPEDANCE PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. THE RIGHT VENTRICULAR LEAD IMPEDANCE WAS FOUND TO OCCASIONALLY DROP BELOW 100 OHMS. THE LEAD WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention