BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 23712718 · Received December 4, 2025

    Report

    Report Number
    2017865-2025-1006544
    Event Type
    Injury
    Date Received
    December 4, 2025
    Report Date
    December 3, 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
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION FOR THIS EVENT WAS OBTAINED FROM A LITERATURE REVIEW ARTICLE: JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, 2025; 36:650¿662. PUBLISHED BY BLACKWELL SCIENCE INC. TITLED "PERMANENT LEFT BUNDLE BRANCH AREA DF-4 DEFIBRILLATOR LEAD IMPLANTATION¿FEASIBILITY, PROCEDURAL CAVEATS, SAFETY, AND FOLLOW-UP" GHOSH A, SRIRAM CS, MANU N, SANKARADAS MA, UPADHYAY GM, PANDURANGI UM. FURTHER INFORMATION WAS UNAVAILABLE DUE TO THE NATURE OF THE SOURCE.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A LITERATURE REVIEW INVESTIGATING THE FEASIBILITY/SUCCESS RATE OF DF-4 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS IN THE BUNDLE BRANCH AREA THAT THE IMPLANT PROTOCOL UTILIZED ABBOTT DURATA 7122Q (DF-4) ICD LEADS. COMPLICATIONS WERE OBSERVED IN 3 OUT OF 12 STUDY PATIENTS IN THE FEASIBILITY STUDY. THE COMPLICATIONS INVOLVED TRANSEPTAL PERFORATION IN 2 PATIENTS AND 1 MICRO-DISLODGEMENT. THE PRE AND POST DIAGNOSED CONDITIONS AND OBSERVATIONS WERE GENERALIZED WITH NO SPECIFIC PRODUCT OR PATIENT INFORMATION. A SUCCESSFUL IMPLANT WAS ACHIEVED IN 75% OF PATIENTS. DETAILS ARE LISTED IN THE ARTICLE JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, 2025; 36:650¿662. PUBLISHED BY BLACKWELL SCI. INC. TITLED "PERMANENT LEFT BUNDLE BRANCH AREA DF-4 DEFIBRILLATOR LEAD IMPLANTATION¿FEASIBILITY, PROCEDURAL CAVEATS, SAFETY, AND FOLLOW-UP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2728841 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR Permanent defibrillator electrodes NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 7122Q

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention