BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 3926168 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15490
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    April 29, 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
    NC, 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 INSULATION BREACH DUE TO CLAVICLE CRUSH AT 23.0 CM TO 23.6 CM FROM THE CONNECTOR PIN; THE OUTER COIL WAS COMPRESSED IN THIS LOCATION. THIS COULD HAVE CAUSED THE REPORTED NOISE PROBLEM, LOSS OF CAPTURE AND INSULATION ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN HOSPITAL FOR EVALUATION AFTER FEELING LIGHT HEADED. UPON INTERROGATION, THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE AND LOSS OF CAPTURE. INSULATION ANOMALY WAS NOTED ON THE LEAD DURING EXTRACTION. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402710 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 1688TC/52, DN206496