BEUDAMED
    FDA Adverse Event Death Summary report: N

    COGNIS

    MDR report key: 2232182 · Received September 2, 2011

    Report

    Report Number
    2124215-2011-15054
    Event Type
    Death
    Date Received
    September 2, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. THE CLINICAL OBSERVATION OF NO INTERROGATION WAS CONFIRMED. ADDITIONALLY, A MEMORY DOWNLOAD COULD NOT BE PERFORMED. VISUAL INSPECTION OF THE DEVICE HEADER AND CASE DID NOT REVEAL ANY DAMAGE BEYOND THAT CONSISTENT WITH EXPLANT OF THE DEVICE. THE CASING OF THE DEVICE WAS REMOVED AND INTERNAL ELECTRICAL MEASUREMENTS REVEALED THAT ONE OF THE TRANSFORMER'S SECONDARY WIRES HAD SHORTED WHICH DAMAGED THE POWER SUPPLY CIRCUITRY DUE TO ELECTRICAL OVERSTRESS. BECAUSE THIS TYPE OF FAILURE OCCURS DURING HIGH ENERGY CHARGING, OUR FAILURE ANALYSIS ENGINEERS WERE ABLE TO CONCLUDE THAT THIS TRANSFORMER MALFUNCTION MOST LIKELY OCCURRED DURING AN AUTOMATIC CAPACITOR REFORMATION. IT WAS CONCLUDED THAT THE ROOT CAUSE OF THE CLINICAL OBSERVATIONS WERE ATTRIBUTED TO AN INTERNAL SHORT WITHIN THE TRANSFORMER RESULTING IN A HIGH CURRENT DRAIN AND RESULTANT INABILITY TO INTERROGATE THE DEVICE. ADDITIONALLY, COLLATERAL DAMAGE TO THE POWER SUPPLY CIRCUITRY PREVENTED THE DEVICE FROM PROVIDING THERAPY WHEN REQUIRED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION IN LATE (B)(6) 2011 THAT THIS PATIENT HAD DIED NINE DAYS FOLLOWING THE REPLACEMENT PROCEDURE. INFORMATION CONCERNING THIS PATIENT'S DEATH AND DEVICE ANALYSIS WILL BE DETAILED IN A SEPARATE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT DIED NINE DAYS FOLLOWING THE REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER-DEPENDENT PATIENT SUFFERED A FALL AND RESULTANT HEAD TRAUMA IN LATE (B)(6) 2011. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER) WITH A HEART RATE OF APPROXIMATELY 12 BPM. A TEMPORARY PACING LEAD WAS INSERTED BECAUSE NO PACING OUTPUT FROM THE DEVICE WAS OBSERVED. A LOCAL BOSTON SCIENTIFIC REPRESENTATIVE WAS CONTACTED TO INTERROGATE THE DEVICE. DESPITE MULTIPLE ATTEMPTS, THE DEVICE COULD NOT BE INTERROGATED. ADDITIONALLY, MULTIPLE ATTEMPTS TO GENERATE BEEPING TONES WITH APPLICATION OF A MAGNET WERE UNSUCCESSFUL. IT WAS REPORTED THAT THE DEVICE HAD BEEN SUCCESSFULLY INTERROGATED AT THE LAST IN-CLINIC FOLLOW-UP APPOINTMENT (ONE MONTH PRIOR TO THIS RECENT HOSPITAL ADMISSION). THE MOST RECENT DATA UPLOAD FROM THIS PATIENT'S MONITORING SYSTEM OCCURRED FIVE DAYS PRIOR TO THIS RECENT HOSPITAL ADMISSION. THE DATA UPLOAD WAS REVIEWED BY A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT WHO CONFIRMED NORMAL/STABLE LEAD DIAGNOSTIC MEASUREMENTS AS OF THAT DATE. THE TS CONSULTANT NOTED THAT NO INDUCTION TESTING HAD BEEN PERFORMED WITH THIS DEVICE AND THAT THE DEVICE COUNTERS SHOWED NO THERAPY SHOCKS HAD BEEN DELIVERED. BASED ON THE REPORTED CLINICAL OBSERVATIONS, TS RECOMMENDED THAT THE PATIENT SHOULD BE SCHEDULED FOR AN IMMEDIATE DEVICE REPLACEMENT PROCEDURE SINCE THE DEVICE WAS CONSIDERED NON-FUNCTIONAL. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REPLACEMENT PROCEDURE WAS TEMPORARILY POSTPONED DUE TO THE PATIENT'S MEDICAL CONDITION. SUBSEQUENTLY, THE PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY IN EARLY (B)(6) 2011 AND THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED WITH A COMPETITOR DEVICE. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    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 68 YR Death| H| L| R H170| 1861| 4538| N119| 4054| 6945