BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 3924105 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15036
    Event Type
    Injury
    Date Received
    July 9, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM FOR UNRELATED LUNG ISSUES. A CHEST X-RAY REVEALED THAT THE LEAD HAD DISLODGED AND LOSS OF CAPTURE WAS ALSO NOTED. THE PATIENT WAS ASYMPTOMATIC. THE LEAD WAS REPOSITIONED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400249 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1882TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention