BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA

    MDR report key: 9506916 · Received December 20, 2019

    Report

    Report Number
    2938836-2019-17405
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Report Date
    December 20, 2019
    Manufacturer
    ABBOTT
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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

    THE ARTICLE IN ITALIAN FEDERATION OF CARDIOLOGY WAS IDENTIFYING THE REASONS FOR LEAD FAILURE BY COMPARING THE DURATA TO THE RIATA LEADS. IT WAS REPORTED THAT INTERNAL INSULATION BREACH WAS THE PRIMARY CAUSE OF LEAD FAILURE IN THE DURATA. SPECIFIC PATIENT INFORMATION IS UNKNOWN. FURTHER INFORMATION IS NOT AVAILABLE. RORDORI R, TARAVELLI E, GIOVANNI B, ET AL. PERFORMANCE OF THE DURATA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD: RESULTS OF AN INDEPENDENT MULTICENTER STUDY. J CARDLOV1111C MED 2019, 20:676-681. DO1:1 0.2459/JCM.0000000000000843.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302398 DURATA DEFIBRILLATION LEAD LWS ABBOTT

    Patients

    Seq Age Sex Outcome Treatment
    1