BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALLANT DR

    MDR report key: 21780637 · Received April 4, 2025

    Report

    Report Number
    2017865-2025-39305
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 17, 2025
    Report Date
    May 6, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF FAILURE TO REMOVE SET SCREW AND A LOOSE SET SCREW WAS CONFIRMED BY ANALYSIS. FINAL ANALYSIS FOUND THE SET SCREW STRIPPED AND THE HEADER DAMAGED. THIS PROBLEM OCCURRED DURING THE PROCEDURE. FINAL ANALYSIS DID NOT FIND ANY ANOMALIES EXCEPT FOR PROCEDURAL DAMAGE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTIONS STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE ELECTROPHYSIOLOGY LAB FOR A LEAD REVISION PROCEDURE DUE TO A HIGH CAPTURE THRESHOLD IN THEIR RIGHT VENTRICULAR (RV) LEAD. UPON HELIX RETRACTION, THIS RV LEAD ALSO EXHIBITED A FAILURE TO EXTEND THE HELIX WHILE TRYING TO RE-POSITION IT. THE RV LEAD WAS EXPLANTED AND REPLACED. BEFORE POCKET CLOSURE, THE NEW RV LEAD HAD PULLED BACK AND WAS REPOSITIONED ON (B)(6) 2025. THE RV LEAD WAS CONNECTED TO THE CHRONIC DEVICE, BUT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SCREW FAILED TO TIGHTEN, AND AFTERWARDS THE SET SCREW COULD NOT BE REMOVED FROM THE HEADER. DURING THE ATTEMPT TO REMOVE THE SET SCREW, THE NEW RV LEAD WAS DAMAGED. THE LEAD WAS RETRIEVED, AND ANOTHER NEW RV LEAD WAS THEN IMPLANTED SUCCESSFULLY. THE PATIENT EXPERIENCED NO CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786310 GALLANT DR NO MATCH NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CDDRA500Q P000217700

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male