BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL

    MDR report key: 9270647 · Received November 3, 2019

    Report

    Report Number
    2938836-2019-15778
    Event Type
    Malfunction
    Date Received
    November 3, 2019
    Report Date
    November 3, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS AND IDENTIFYING PRODUCTS INFORMATION WAS NOT PROVIDED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENTS COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABBOTT TENDRIL LEADS THAT MAY BE RELATED TO LEAD MALFUNCTION, INCLUDING INAPPROPRIATE NOISE WITH OVERSENSING, INSULATION BREACH, FAILURE TO CAPTURE, OR IMPEDANCE ISSUES. SPECIFIC PATIENT INFORMATION IS UNKNOWN. ACCORDING TO THE ARTICLE, MOST OF THESE PATIENTS WITH AFFECTED LEADS WERE ASYMPTOMATIC AND COULD BE MANAGED CONSERVATIVELY. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED ¿INAPPROPRIATE NOISE DETECTION IN TENDRIL FAMILY PACING LEADS¿. ZHU DWX, CHU MM, ZAGER AJ, ET AL. INAPPROPRIATE NOISE DETECTION IN TENDRIL FAMILY PACING LEADS. J CARDIOVASC ELECTROPHYSIOL. 2019;1-8.HTTPS://DOI.ORG/10.1111/JCE.14194.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064928 TENDRIL TENDRIL NVN ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)

    Patients

    Seq Age Sex Outcome Treatment
    1