BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 3802570 · Received May 9, 2014

    Report

    Report Number
    2017865-2014-13781
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 25, 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
    CA, 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 THE RIGHT ATRIAL LEAD EXHIBITED AN INSULATION ANOMALY. THE LEAD WAS CAPPED AND REPLACED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES: IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, NOISE WAS DETECTED ON THE LEAD. THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281861 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention