BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3211327 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08176
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL BE EVALUATED UPON RETURN. THIS PRODUCT ISSUE WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. EVALUATION CONFIRMED THE CLINICAL OBSERVATION OF THE FAULT CODE 1009. VISUAL INSPECTION NOTED A LARGE ARC MARK ON THE DUMP RESISTOR WHICH IS LOCATED NEXT TO THE BATTERY AND THERE IS A CLEAR PLASTIC LINER OVER BOTH THE BATTERY AND DUMP RESISTOR. THE LINER PROVIDES A SHIELD BETWEEN THE BATTERY/DUMP RESISTOR AND THE DEVICE BACK CASE HALF. THE OVERSTRESS DAMAGE IS EVIDENT OF THE SURFACE OF THE BATTERY, ON BOTH SIDES OF THE DUMP RESISTOR, ON THE PLASTIC LINER AND FINALLY ON THE BACKSIDE OF THE DEVICE CASE. THE MAJORITY OF THE DAMAGE IS ON THE SIDE OF THE RESISTOR THAT FACES AWAY FROM THE BATTERY. DUE TO THE EXTENSIVE DAMAGE, IT CANNOT BE DETERMINED WHAT THE ROOT CAUSE OF THE OVERSTRESS WAS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE EXHIBITED A FAULT CODE (FC) 1009 UPON INTERROGATION. THE DEVICE WAS EXPLANTED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311731 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L H175| N118| 4518| 0158