BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 21495800 · Received February 28, 2025

    Report

    Report Number
    2017865-2025-15411
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    February 13, 2025
    Report Date
    April 7, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RELATED MANUFACTURING REPORT: 2017865-2025-15405. IT WAS REPORTED PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE. IT WAS ALSO PREVIOUSLY NOTED THAT THE RV LEAD EXHIBITED UNSPECIFIED ANOMALIES IN IMPEDANCE, THRESHOLD, AND R WAVE AMPLITUDE, DUE TO LEAD DISLODGEMENT, WHICH WAS CONFIRMED BY CHEST X-RAY. THE RV LEAD WAS REPOSITIONED PREVIOUSLY ON (B)(6) 2025. DURING RV LEAD REVISION, IT WAS FOUND THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SETSCREW WAS UNABLE TO BE TIGHTENED. UPON FLUOROSCOPY IMAGING, IT WAS DISCOVERED THAT THE RV LEAD WAS PROTRUDED FROM THE ICD CONNECTOR, AND THE SETSCREW WAS FURTHER DAMAGED. THE HIGH PACING IMPEDANCE WAS ALLEGED TO BE AN ICD ISSUE, SINCE IT WAS RESOLVED BY EXPLANTING AND REPLACING THE ICD. THE RV LEAD REMAINS IMPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING IMPEDANCE AND HIGH CAPTURE THRESHOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375631 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR PERMANENT DEFIBRILLATOR ELECTRODES NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 7122Q/58 A000160509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention