BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2161600 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07081
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THESE PRODUCTS REMAIN IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT A LEAD REVISION MAY BE SCHEDULED IN THE FUTURE.

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THIS LEAD WAS SURGICALLY ABONDONED AND A NEW LEAD WAS IMPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIOVERTER RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED A RISE IN SHOCK IMPEDANCES FROM 60 OHMS AT DEFIBRILLATION TESTING AT IMPLANT TO NOW GREATER THAN 100 OHMS IN TRIAD CONFIGURATION. THERE WERE OBSERVED GREATER THAN 125 OHMS WHEN PROGRAMMED RV COIL TO CAN. THIS PATIENT ALSO HAD DEVICE STIMULATION ISSUES, BUT THIS WAS RESOLVED WITH REPROGRAMMING. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 75 YR T135| N119| 1790| 0144| 4592