BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 3926136 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15466
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 16, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CHEST X-RAY TAKEN ONE DAY POST IMPLANT SHOWED THE TENSION ON ATRIAL LEAD WAS VERY TIGHT. THE POCKET WAS OPENED TO ADJUST THE SLACK ON THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403120 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688TC/40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention