BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2172869 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-11178
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 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

    THE DEVICE REMAINS IN SERVICE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS ADMITTED TO THE HOSPITAL WITH A HEART RATE OF 9 BEATS PER MINUTE WITH ASYSTOLE DUE TO INTERMITTENT CAPTURE. THE PATIENT WAS LIGHTHEADED AND NEAR BUT NOT YET SYNCOPAL UPON ADMITTANCE. IT WAS NOTED THAT THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD IMPEDANCE HAD INCREASED TO 1600 OHMS, AND THE LEFT VENTRICULAR (LV) LEAD IMPEDANCE HAD INCREASED TO 1800 OHMS. ADDITIONALLY, THE THRESHOLDS FOR THE LEFT AND RIGHT VENTRICULAR LEADS HAD ALSO INCREASED. MULTIPLE STORED EPISODES OF PACING INHIBITION AND NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES DUE TO NOISE WERE ALSO NOTED, WITH AN UNKNOWN LENGTH OF ASYSTOLE. A CHEST X-RAY WAS TAKEN, AND IT WAS OBSERVED THE LEADS MAY HAVE BEEN TWISTED SLIGHTLY DUE TO POSSIBLE TWIDDLER'S SYNDROME, HOWEVER, STILL REMAINED IN CONTACT WITH THE CARDIAC TISSUE. INFORMATION WAS RECEIVED THAT A LEAD REVISION HAD TAKEN PLACE, AND THE NON-BOSTON SCIENTIFIC RV LEAD WAS SURGICALLY ABANDONED, AND THE RATE/SENSE PORTION OF A PREVIOUSLY SURGICALLY ABANDONED TRANSVENOUS LEAD WAS USED. DURING THE PROCEDURE, SLIGHT DAMAGE WAS NOTED ON THE NON-BOSTON SCIENTIFIC RV LEAD AND THE RIGHT ATRIAL LEAD, AND WAS REPAIRED SUCCESSFULLY. 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 74 YR Hospitalization 4542| MISMATCH| 1290| 0185| N119| 4470