BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3041229 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02887
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 13, 2013
    Report Date
    February 12, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL REVIEW, THIS FAMILY OF DEVICES HAS BEEN SPECIFICALLY DESIGNED SUCH THAT IF THREE SYSTEM RESETS OCCUR WITHIN APPROXIMATELY 48 HOURS, A DEVICE WILL ENTER SAFETY MODE. THE BEHAVIOR OF THIS DEVICE IS CONSISTENT WITH DEVICES THAT HAVE REVERTED TO SAFETY MODE DUE TO ELECTROCAUTERY. DESIGN CHANGES HAVE NOW BEEN IMPLEMENTED TO ENHANCE THE ROBUSTNESS OF ELECTRIC CIRCUITS, SUCH THAT A DEVICE WOULD BE ABLE TO WITHSTAND THE RARE OCCURRENCES OF CONDUCTED ENERGY THAT PREVIOUSLY WOULD HAVE DISRUPTED CIRCUIT PERFORMANCE.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM RECENTLY HAD A LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTED. THIS CRT-D WAS PROGRAMMED OFF DURING THE LVAD IMPLANT, HOWEVER, UPON INTERROGATION POST PROCEDURE THE DEVICE WAS IN SAFETY MODE. THE FIELD REPRESENTATIVE DISCUSSED WITH THE PHYSICIAN THAT SAFETY MODE HAS UNIPOLAR PACING AND SENSING. APPARENTLY, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF) DURING THE LVAD IMPLANT AND THE DEVICE DELIVERED A SHOCK FOR THE VF. SINCE THE DEVICE HAD BEEN OFF, IT MUST HAVE GONE INTO SAFETY MODE DURING THE PROCEDURE IN ORDER TO SHOCK. THE PHYSICIAN ELECTED TO LEAVE THE CRT-D ON. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED RELATED TO THIS OBSERVATION. SIXTEEN DAYS LATER THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS BEING ATTRIBUTED TO COMPLICATIONS FROM THE LVAD IMPLANT AND THE PATIENT'S UNDERLYING CONDITION. THERE WERE NO ALLEGATIONS THAT THE CRT-D CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE FIELD REPRESENTATIVE REQUESTED THE CRT-D BE RETURNED TO BOSTON SCIENTIFIC BUT EVIDENCE SUGGESTS THE DEVICE WAS NOT EXPLANTED POST-MORTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143787 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4470| MISMATCH| T177| 0185| N119