BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 16896980 · Received May 9, 2023

    Report

    Report Number
    2017865-2023-19513
    Event Type
    Death
    Date Received
    May 9, 2023
    Date of Event
    March 31, 2023
    Report Date
    May 9, 2023
    Manufacturer
    ABBOTT
    Product Code
    NVY
    UDI-DI
    05414734503341
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL WITH CHEST PAIN. UPON INVESTIGATION, THE RIGHT VENTRICULAR (RV) LEAD PERFORATION RESULTING IN A HEMOTHORAX AND A RIGHT VENTRICLE WALL RUPTURE WAS OBSERVED VIA DIAGNOSTIC IMAGING. ADDITIONALLY, LOW SENSING WAS OBSERVED ON THE RV LEAD. AN ATTEMPT TO REPOSITION THE RV LEAD WAS MADE, HOWEVER, THE PATIENT'S CONDITION WORSENED. THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE UNIT WHERE A CHEST DRAIN WAS PERFORMED. THE PATIENT PASSED AWAY AT A LATER DATE AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800849 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ABBOTT 7122Q/65 A000098386 05414734503341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D| O