BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2062466 · Received April 19, 2011

    Report

    Report Number
    2124215-2011-06828
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 11, 2011
    Report Date
    June 24, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0609-10 TO Z-0610-10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR (B)(4) LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A WEAKENED HEADER BOND. IT WAS NOTED THAT ON THREE SIDES OF THE HEADER, MEDICAL ADHESIVE WAS BONDED TO THE HEADER, BUT NOT THE CORRESPONDING AREA OF THE DEVICE CASE. AN X-RAY OF THE DEVICE HEADER FOUND FIVE OF THE FEED-THROUGH WIRES TO BE ELECTRICALLY OPEN. ONE FEED-THROUGH WIRE WAS OBSERVED TO BE CRACKED. A REVIEW OF DEVICE MEMORY REVEALED THAT THE CIRCUITS BECAME OPEN AT DIFFERENT STAGES OF THE DEVICE IMPLANT. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE. IT WAS UNABLE TO BE DETERMINED IF THE DEVICE HAD BEEN IMPLANTED SUB-PICTORIALLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A LOCAL COMPETITOR FIELD REPRESENTATIVE THAT THE HEADER OF THIS DEVICE BECAME DISASSOCIATED FROM THE BODY OF THE DEVICE. THIS WAS REPORTED TO HAVE HAPPENED APPROXIMATELY TWO YEARS AFTER IMPLANT. THE DEVICE WAS EXPLANTED AND WAS BEING SENT BACK TO THE COMPETITIVE COMPANY. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| R (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)