BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1962309 · Received January 18, 2011

    Report

    Report Number
    2124215-2011-00867
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 30, 2010
    Report Date
    February 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS. UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A WEAKENED HEADER BOND. NO BODY FLUID INFILTRATION WAS NOTED UNDER THE HEADER. AN X-RAY OF THE DEVICE HEADER FOUND THE DF- HEADER WIRE WAS FRACTURED. ALL OTHER HEADER WIRES WERE INTACT. DETAILED ANALYSIS REVEALED THAT THE HEADER WIRE FRACTURED DUE TO FATIGUE. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A WEAKENED HEADER BOND. NO BODY FLUID INFILTRATION WAS NOTED UNDER THE HEADER. AN X-RAY OF THE DEVICE HEADER FOUND THE DF- HEADER WIRE WAS FRACTURED. ALL OTHER HEADER WIRES WERE INTACT. DETAILED ANALYSIS REVEALED THAT THE HEADER WIRE FRACTURED DUE TO FATIGUE. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING A ROUTINE FOLLOW-UP APPOINTMENT, IT WAS SUSPECTED THIS DEVICE HAD A HEADER MALFUNCTION. THE DEVICE WAS IMPLANTED SUBPECTORALLY, AND IS PART OF THE SUBPECTORAL IMPLANT 2009 PRODUCT ADVISORY, INITIALLY COMMUNICATED ON (B)(6)2009. A REPLACEMENT PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED AND REPLACED. THE ASSOCIATED LEADS WERE TESTED WITH A PACING SYSTEM ANALYZER DURING THE PROCEDURE AND HAD ACCEPTABLE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THAT A SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS HAD BEEN MEASURED WHILE IMPLANTED. PRESSURE APPLIED TO THE HEADER OF THE DEVICE WHILE IMPLANTED CAUSED THE IMPEDANCE TO TEMPORARILY NORMALIZE. AT THE DEVICE EXPLANT, A HEADER SEPARATION WAS NOTED. DAMAGE TO THE HEADER FEED THROUGH WIRES WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention