BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1953618 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24319
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 10, 2010
    Report Date
    June 21, 2024
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012/S165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THIS UPGRADE PROCEDURE FROM A PACEMAKER TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR NOISE WAS OBSERVED WHEN THE RIGHT VENTRICULAR PACE-SENSE LEAD WAS CONNECTED TO THE DEVICE. THIS RESULTED IN INHIBITION OF PACING AND WAS RECREATED WITH LEAD MOTION. WHEN THE PHYSICIAN THEN CONNECTED THE NEW DEFIBRILLATION LEAD TO THE DEVICE, INHIBITION OF PACING FOR SEVERAL SECONDS WAS OBSERVED AFTER THE DEVICE WAS PLACED IN THE POCKET. THE PHYSICIAN SUSPECTED A DEVICE HEADER ISSUE AND SPECIFIC CONCERN WAS THAT THE SEAL PLUG BECAME DAMAGED WITH THE WRENCH DURING TIGHTENING. THE PHYSICIAN ELECTED TO USE A NEW DEVICE FOR IMPLANT. NO ADVERSE PATIENT EFFECTS WERE EXPERIENCED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male 1291| 4135| 4137| 4137| 4135| 1291