BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 3924128 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15056
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 1, 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
    TX, 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 DURING THE POST-OP CHECK, THE PATIENT COMPLAINED OF PAIN AND UPON INTERROGATION, THE ATRIAL LEAD EXHIBITED LOSS OF CAPTURE. IT WAS NOTED THAT THE LEAD HAD PERFORATED THE MID LATERAL WALL RESULTING IN HEMOTHORAX ON THE RIGHT SIDE. A LAPAROSCOPIC PROCEDURE WAS PERFORMED TO REMOVE BLOOD FROM THE PERFORATED AREA. THE LEAD WAS EXPLANTED AND REPLACED ON 5/13/14. THE PATIENT WAS IN STABLE AND GOOD HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399311 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention