BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 8444233 · Received March 22, 2019

    Report

    Report Number
    2017865-2019-03834
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Report Date
    March 22, 2019
    Manufacturer
    ABBOTT
    Product Code
    DTB
    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 REPORT IN AN ARTICLE WITHIN THE JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY IDENTIFYING QUARTET LEADS WITH HIGH PACING THRESHOLDS. SPECIFIC PATIENT INFORMATION WAS NOT REVEALED. DETAILS ARE LISTED IN THE ARTICLE, CICONTE, GIUSEPPE & CALOVIC, ZARKO ET. AL (2018). MULTIPOINT LEFT VENTRICULAR PACING IMPROVES RESPONSE TO CARDIAC RESYNCHRONIZATION THERAPY WITH AND WITHOUT PRESSURE-VOLUME LOOP OPTIMIZATION: COMPARISON OF THE LONG-TERM EFFICACY OF TWO DIFFERENT PROGRAMMING STRATEGIES POINT. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY, 54(2), 141-149. HTTPS://DOI.ORG/10.1007/S10840-018-0480-6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237794 PERMANENT PACEMAKER ELECTRODE DTB ABBOTT LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1