BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1874047 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-19303
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    August 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE COMPLETE LEAD WAS RETURNED WITH THE HELIX RETRACTED, DRIED TISSUE ON THE HELIX AND DRIED BLOOD PAST THE HELIX MECHANISM UP THROUGH THE LEAD LUMEN. FURTHER VISUAL INSPECTION NOTED SEVERAL CUTS IN THE SILICONE INSULATION AND INSULATION SEPARATION BETWEEN THE ANODE RING AND HELIX HOUSING. DEFORMED CONDUCTOR COILS AT 146 MM AND LEAD ON LEAD ABRASION FROM 377 TO 382 MM WERE ALSO NOTED. INITIAL LABORATORY ANALYSIS OBSERVED THAT THE CATHODE COILS WERE FRACTURED FROM THE TERMINAL PIN. THE LEAD WAS SENT FOR DETAILED ANALYSIS. ANALYSIS RESULTS WILL BE UPDATED UPON COMPLETION OF THE DETAILED ANALYSIS.

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS INVESTIGATION FOUND THAT THIS ISSUE IS LIKELY DUE TO HELIX MECHANISM OVERTORQUE, WHICH EXCEEDS THE WELD DESIGN STRENGTH.

    Additional Manufacturer Narrative · 1

    DETAILED ANALYSIS CONFIRMED THAT THE INNER COIL TO THE TERMINAL PIN WELD WAS FRACTURED AT APPROXIMATELY 12 MM. EXAMINATION OF THE COIL SIDE OF THE FRACTURE SHOWED THAT ALL THREE OF THE COIL FILARS WERE WELDED; THEREFORE THERE IS NO INDICATION THAT THE WELD WAS WEAK. THE FRACTURE SURFACE WAS COVERED WITH DUCTILE DIMPLES INDICATING FAILURE BY OVERLOAD FORCE THAT EXCEEDED THE STRENGTH OF THE MATERIALS. ANALYSIS WAS NOT ABLE TO CONFIRM THE ALLEGATION OF INTERMITTENT LOSS OF CAPTURE. HOWEVER, THE ALLEGATION OF DIFFICULTY INSERTING THE STYLET INTO THE LEAD WAS CONFIRMED AS THE CATHODE COILS WERE FOUND TO BE FRACTURED FROM THE TERMINAL PIN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITIED INTERMITTENT LOSS OF CAPTURE. THE PATIENT IS PACED 32% OF TIME IN THE VENTRICLE, IS NOT PACEMAKER DEPENDENT AND THERE WAS NO ASYSTOLE GREATER THAN TWO SECONDS. IT WAS NOTED THAT THE PHYSICIAN PLANNED TO REPOSITION THE LEAD, HOWEVER DURING THE LEAD REVISION PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY INSERTING THE STYLET INTO THE RV LEAD. THE LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. IT WAS ALSO NOTED THAT THE PATIENT HAD ATRIAL FIBRILLATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| R 4087| S401| 4136| 4086| 1290