BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 3925759 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15239
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 15, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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 A NON-DEPENDENT PATIENT PRESENTED IN THE HOSPITAL DUE TO MUSCLE STIMULATION. THE VENTRICULAR LEAD EXHIBITED LOW IMPEDANCE IN BIPOLAR CONFIGURATION. NOISE AND HIGH PACING THRESHOLD WERE ALSO NOTED. AN INSULATION ANOMALY WAS SUSPECTED. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404920 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1888TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention