BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1852906 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-18933
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 14, 2010
    Report Date
    September 30, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, INFORMATION INDICATES THAT THIS CRT-D WAS REMOVED FROM SERVICE. THE COMPETITOR'S RV LEAD WAS ALSO REMOVED FROM SERVICE AS A RESULT OF FRACTURE. MOST RECENTLY, THIS MEDICAL DEVICE HAS BEEN RETURNED TO THE BOSTON SCIENTIFIC CRM POST MARKET QUALITY ASSURANCE LABORATORY BUT ANALYSIS REMAINS INCONCLUSIVE TO DATE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RETURN TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS CONFIRMED THIS CRT-D HAD BEEN IN SAFETY CORE AS A RESULT OF ELECTROCAUTERY DAMAGE. VISUAL INSPECTION OF THE DEVICE CASE NOTED OBSERVATION OF ELECTROCAUTERY DAMAGE TO THE CASE. IT WAS ALSO CONFIRMED THAT THE DEVICE HAD LOGGED MULTIPLE OSCILLATOR DEVIATION FAULTS THAT CAN COMMONLY OCCUR DURING AN ELECTROCAUTERY PROCEDURE DURING THE IMPLANT OR EXPLANT OF A DEVICE. FURTHER ANALYSIS CONFIRMED THE DEVICE SETSCREWS PERFORMED WITHIN NORMAL LIMITS. RV IMPEDANCE ALSO MEASURED WITHIN NORMAL LIMITS. THE RV PORT PIN GAUGE TEST PASSED. THEREFORE, THE ALLEGATION OF THE HIGH RV PACE IMPEDANCE COULD NOT BE CONFIRMED. AS OF THIS REPORT, INVESTIGATION IS CONCLUDED. IF NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IN ASSOCIATION WITH THE COMPETITOR'S TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS >2,000 OHMS. THERE WAS LOSS OF CAPTURE FOR THIS PACEMAKER DEPENDENT PATIENT. THE PATIENT WAS BEING PACED FROM THE LEFT VENTRICULAR (LV) LEAD. INAPPROPRIATE ANTI-TACHYCARDIA PACING DID OCCUR AS A RESULT OF OVERSENSING. IT WAS DETERMINED THAT THE COMPETITOR'S RV LEAD HAD FRACTURED AND A SURGICAL INTERVENTION TO CORRECT THIS ISSUE WAS IMMINENT. IT WAS FURTHER NOTED THAT THIS CRT-D MAY HAVE SUBSEQUENTLY REVERTED TO SAFETY CORE.

    Description of Event or Problem · 1

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    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 83 YR H177| 1194| 0185| MISMATCH| 6949| 4549| N119