BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 4140472 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17301
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 21, 2014
    Report Date
    October 29, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THAT ALL SEAL PLUGS WERE INTACT AND IT WAS VERIFIED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD HAD BEEN FULLY INSERTED WHILE IMPLANTED BY EVIDENCE OF THE LEAD SEAL RING MARKS IN THE HEADER RA AND RV PORTS. VISUAL INSPECTION NOTED SEVERAL ELECTROCAUTERY MARKS ON THE DEVICE CASE. THE DEVICE WAS SUCCESSFULLY PROGRAMMED OUT OF SAFETY MODE, RESTORING THE DEVICE TO THE CONDITION IT WAS IN JUST PRIOR TO ENTERING SAFETY MODE AND THE DEVICE CAME UP IN ELECTROCAUTERY MODE. THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING AND RECORDING FUNCTIONS OF THE DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE AND NON-BSC RIGHT VENTRICULAR (RV) LEAD WAS REPORTEDLY KICKED IN THE CHEST, NEAR THE DEVICE AREA. THE PATIENT WAS PRESENTED IN THE EMERGENCY ROOM, WHERE IT WAS CONFIRMED THAT THE DEVICE SYSTEM DELIVERED MULTIPLE INAPPROPRIATE SHOCKS AS A RESULT OF NOISE AND OVERSENSING. FURTHER INTERROGATION DISPLAYED UNSPECIFIED FAULT CODES AND THAT THE DEVICE HAD ENTERED INTO SAFETY MODE. A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE SYSTEM WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618816 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R T125| N119| 6949| 4456| 1298| 5071| 7304| MISMATCH| 4469