BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 4131777 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-13927
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 11, 2014
    Report Date
    August 6, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. HIGH POWER VISUAL INSPECTION NOTED THAT THE HEADER WAS LOOSE ON TOP OF THE DEVICE CASE. THERE WAS NO MEDICAL ADHESIVE ON THE DEVICE CASE AND ALL THE MEDICAL ADHESIVE WAS STILL ON THE BOTTOM OF THE HEADER. ELECTROCAUTERY MARKS WERE NOTED IN THE HEADER. REVIEW OF THE MEMORY NOTED SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS DURING THE IMPLANT TIME. HOWEVER, THERE WERE NO OUT OF RANGE MEASUREMENTS IN THE DAILY MEASUREMENTS DURING THE IMPLANT TIME. X-RAY NOTED TWO FEED THRU WIRES WERE FRACTURED. DURING IMPEDANCE MEASUREMENT TESTING, THE HEADER WAS FLEXED AND HIGH PACE AND SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED. AS A RESULT, THE CLINICAL OBSERVATIONS WERE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A REVISION PROCEDURE WAS BEING PERFORMED DUE TO HIGH SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS ON THE RIGHT VENTRICULAR (RV) LEAD. A NEW RV LEAD WAS IMPLANTED AND ALL MEASUREMENTS WERE APPROPRIATE PRIOR TO CONNECTING THE LEAD TO THE CHRONIC DEVICE. WHEN THE NEW RV LEAD WAS CONNECTED TO THE CHRONIC DEVICE, THE SHOCK IMPEDANCE MEASUREMENTS WERE GREATER THAN 200 OHMS AND THERE WAS A DROP OUT OF PACING IN THIS PACEMAKER DEPENDENT PATIENT. THE DEVICE HEADER WAS EXAMINED AND FOUND TO BE BROKEN. WHEN THE HEADER WAS MANIPULATED, THE DROP OUT ON PACING WAS OBSERVED. AS A RESULT, THE DEVICE WAS EXPLANTED AND A NEW DEVICE WAS IMPLANTED. THE CHRONIC RV LEAD EXHIBITED APPROPRIATE MEASUREMENTS WITH THE NEW DEVICE AND REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612943 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R G141| 0185| 4591| 4096| P107| 0181