BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE 4-FRONT

    MDR report key: 13443396 · Received February 3, 2022

    Report

    Report Number
    2124215-2022-02954
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    November 1, 2021
    Report Date
    February 3, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526592867
    PMA / PMN Number
    P910073/S145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, AN EVALUATION OF THIS LEAD WAS PERFORMED. COMPLETE LEAD WAS RETURNED INTACT AND NOT SEVERED. THE EZ CONNECTOR TOOL RETURNED ON THE LEAD WAS SEATED PROPERLY, WITH THE FIXATION KNOB OPEN. THERE WAS AN EXTREMELY BENT STYLET RETURNED IN LEAD THAT WAS LIKELY REMOVED WITH SOME FORCE. CUTS IN THE INSULATION WAS ALSO NOTED WHICH WAS LIKELY INDUCED. THE POLY INSULATION SLEEVE WAS BUNCHED. VISUAL INSPECTION NOTED THE POLYTETRAFLUOROETHYLENE WAS BUNCHED IN 3 PLACES BETWEEN 210-226 MILLIMETERS (MM), WHICH WERE PUSHING ON THE COILS CAUSING THE COILS TO BE OFFSET AT THESE LOCATIONS AS WELL. THE LEAD PASSED CONTINUITY TESTING INDICATING CONDUCTORS WERE INTACT. THE LEAD ALSO PASSED HIPOT TEST INDICATING NO ELECTRICAL SHORTS BETWEEN CONDUCTORS. A STYLET INSERTION TEST PASSED -WITH SOME RESISTANCE FELT DUE TO THE BUNCHED INSULATION PUSHING ON THE CONDUCTOR COILS. LABORATORY ANALYSIS CONFIRMED THE REPORTED ALLEGATION.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, AN EVALUATION OF THIS LEAD WAS PERFORMED. COMPLETE LEAD WAS RETURNED INTACT AND NOT SEVERED. THE EZ CONNECTOR TOOL RETURNED ON THE LEAD WAS SEATED PROPERLY, WITH THE FIXATION KNOB OPEN. THERE WAS AN EXTREMELY BENT STYLET RETURNED IN LEAD THAT WAS LIKELY REMOVED WITH SOME FORCE. CUTS IN THE INSULATION WAS ALSO NOTED WHICH WAS LIKELY INDUCED. THE POLY INSULATION SLEEVE WAS BUNCHED. VISUAL INSPECTION NOTED THE POLYTETRAFLUOROETHYLENE WAS BUNCHED IN 3 PLACES BETWEEN 210-226 MILLIMETERS (MM), WHICH WERE PUSHING ON THE COILS CAUSING THE COILS TO BE OFFSET AT THESE LOCATIONS AS WELL. THE LEAD PASSED CONTINUITY TESTING INDICATING CONDUCTORS WERE INTACT. THE LEAD ALSO PASSED HIPOT TEST INDICATING NO ELECTRICAL SHORTS BETWEEN CONDUCTORS. A STYLET INSERTION TEST PASSED -WITH SOME RESISTANCE FELT DUE TO THE BUNCHED INSULATION PUSHING ON THE CONDUCTOR COILS. LABORATORY ANALYSIS CONFIRMED THE REPORTED ALLEGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD BODY WAS A CASE OF AN ATTEMPTED IMPLANT DUE TO LEAD BODY DAMAGED AND STYLET WAS UNABLE TO REMOVE FROM THE LEAD BODY. THIS LEAD WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD BODY WAS A CASE OF AN ATTEMPTED IMPLANT DUE TO LEAD BODY DAMAGED AND STYLET WAS UNABLE TO REMOVE FROM THE LEAD BODY. THIS LEAD WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372351 RELIANCE 4-FRONT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0673 151731 00802526592867

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male