BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA

    MDR report key: 9257462 · Received October 30, 2019

    Report

    Report Number
    2938836-2019-15736
    Event Type
    Injury
    Date Received
    October 30, 2019
    Report Date
    October 30, 2019
    Manufacturer
    ABBOTT
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABBOTT RIGHT VENTRICULAR (RV) LEADS THAT MAY BE RELATED TO MALFUNCTION, INCLUDING IMPEDANCE ISSUES, CAPTURE THRESHOLD ISSUES, NOISE OVERSENSING, AND DISLODGEMENT. THE EVENTS WERE RESOLVED WITH LEAD REPLACEMENT. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. RORDORF R, TARAVELLI E, FORLEO GB, ET AL. PERFORMANCE OF THE DURATA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD: RESULTS OF AN INDEPENDENT MULTICENTER STUDY. J CARDIOVASC MED 2019, 20:676¿681. HTTPS ://DOI. ORG/10.2459/JCM.0000000000000843.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048571 DURATA DEFIBRILLATION LEAD NVY ABBOTT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R