BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3053635 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05271
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 27, 2013
    Report Date
    May 2, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THIS DEVICE HAS BEEN RETURNED, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE HEADER WAS CONFIRMED TO BE FULLY AFFIXED TO THE DEVICE CASE. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. ADDITIONAL HIGH-POWERED VISUAL INSPECTION OF THE RV LEAD PORT NOTED FAINT SEAL RING MARKS WITHIN THE PORT. HOWEVER, THE LOCATION OF THE SEAL RING MARKS SUGGEST THAT THE RV LEAD WAS NOT FULLY INSERTED INTO THE RV LEAD PORT. AN IS-1 LEAD WAS THEN INSERTED INTO THE PORT AND THE SEAL RINGS WERE ALIGNED WITH THE SEAL RING MARKS IN THE LEAD PORT. IN THIS LOCATION, THE LEAD WAS CONFIRMED TO BE UNDER-INSERTED IN THE LEAD PORT. THE TIP OF THE LEAD ENTERED INTO THE RV TIP CONNECTOR BLOCK; HOWEVER, IT DID NOT FULLY PASS THROUGH IT, AS IT SHOULD IF THE LEAD WAS FULLY INSERTED. THE SETSCREW WAS THEN ENGAGED AND THE LEAD TIP WAS INSERTED FAR ENOUGH FOR THE SETSCREW TO MAKE CONTACT WITH IT, BUT BECAUSE THE LEAD WAS UNDER-INSERTED, IT IS LIKELY THAT THE PROXIMAL RING WAS NOT PROPERLY POSITIONED TO ENSURE A SECURE CONNECTION WITH THE PROXIMAL SPRING CONTACTS. ELECTRICAL TESTING THEN WAS PERFORMED WITH THE LEAD IN THIS UNDER-INSERTED POSITION, AND NOISE AND OVERSENSING WERE OBSERVED WHEN THE DEVICE WAS MANIPULATED. THE LEAD WAS THEN FULLY INSERTED INTO THE LEAD BARREL AND THE ELECTRICAL TESTING WAS REPEATED. NO ADDITIONAL NOISE OR OVERSENSING ISSUES WERE OBSERVED. AS A RESULT, EVIDENCE STRONGLY SUGGESTS THAT THE RV LEAD WAS UNDER-INSERTED IN THE LEAD PORT, WHICH RESULTED IN THE CLINICAL OBSERVATIONS OF OVERSENSING AND INAPPROPRIATE THERAPY. THE DEVICE WAS ALSO EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE EXPERIENCED SEVERAL EPISODES OF ANTI-TACHYCARDIA PACING (ATP) HAD OCCURRED AND PRESENTED FOR A FOLLOW UP VISIT. MANIPULATING THE POCKET REVEALED RIGHT VENTRICULAR CHANNEL OVERSENSING RIGHT VENTRICULAR LEAD INSULATION DAMAGE WAS SUSPECTED. A REVISION PROCEDURE WAS PERFORMED. AFTER THE POCKET WAS OPENED, VISUAL OBSERVATION REVEALED NO LEAD ISSUE. THE DEVICE HEADER WAS MANIPULATED REVEALING OVERSENSING THAT RESULTED IN PACING INHIBITION AND THE PATIENT BECAME PRESYNCOPAL. A DECISION WAS MADE TO REPLACE THIS DEVICE. A DEVICE HEADER ISSUE WAS SUSPECTED. POST REPLACEMENT IMPLANT THE REPLACEMENT DEVICE WAS RECONNECTED TO THE CHRONIC RIGHT VENTRICULAR LEAD AND ACCEPTABLE MEASUREMENTS WERE OBTAINED. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156765 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R