BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3212444 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09408
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A WEAKENED HEADER BOND. X-RAY EXAMINATION WAS PERFORMED. THE HEADER WIRES WERE FOUND TO BE FRACTURED AND THERE WAS EVIDENCE OF ARCING DAMAGE. DEVICE MEMORY ALSO VERIFIED THAT THE DAILY SHOCK LEAD IMPEDANCE MEASUREMENTS WERE SATURATED/OPEN FOR AT LEAST THE LAST YEAR WITH OCCASIONAL INTERMITTENT CONTACT WHICH IS CONSISTENT WITH A FRACTURED FEED-THRU WIRE DUE TO A LOOSE HEADER. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS HOSPITALIZED FOR SEVERAL VENTRICULAR TACHYCARDIA (VT) EPISODES. THE ARRHYTHMIAS WERE SUCCESSFULLY TERMINATED BUT THE SHOCK IMPEDANCES WERE ABNORMAL. THERE HAD BEEN PREVIOUS ALERTS FOR HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS INDICATING AN RIGHT VENTRICULAR (RV) LEAD ISSUE. A LEAD REVISION WAS BEING PERFORMED, HOWEVER, WHEN A NEW LEAD WAS CONNECTED TO THIS CRT-D, THE ISSUE REMAINED. A NEW DEVICE WAS THEN ATTACHED TO THE CHRONIC RV LEAD AND SHOCK IMPEDANCES WERE NORMAL. THIS DEVICE HAS BEEN RETURNED FOR ANALYSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314160 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R 0185| 0158| 4470| N119| N141| 4591