BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 3923316 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14599
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 28, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION INCLUDED. FINAL ANALYSIS FOUND THAT THE LEAD WAS RECEIVED IN TWO PIECES. INSULATION DAMAGE WAS NOTED AT 17.0 CM FROM THE CONNECTOR PIN; CONSISTENT WITH THE SUTURE SLEEVE TIE DAMAGE. THIS COULD HAVE CONTRIBUTED TO THE REPORTED NOISE PROBLEM AND LOW IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR SENSE PACE LEAD EXHIBITED NOISE; THE LEAD WAS FRACTURED. CLAVICLE CRUSH DAMAGE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401325 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1888TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention 1580/65 RE49536