BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 3924248 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15155
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 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
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE FOLLOW-UP, AND UPON INTERROGATION, NOISE AND LOW IMPEDANCE WERE OBSERVED ON THE ASYMPTOMATIC PATIENTS RIGHT VENTRICULAR LEAD. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399899 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1488TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention