BEUDAMED
    FDA Adverse Event Death Summary report: N

    COGNIS

    MDR report key: 1349969 · Received March 23, 2009

    Report

    Report Number
    2124215-2009-06091
    Event Type
    Death
    Date Received
    March 23, 2009
    Date of Event
    February 12, 2009
    Report Date
    March 23, 2009
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAVED TO DISK WAS REVIEWED; HOWEVER NO CONCLUSIVE ANALYSIS CAN BE PERFORMED FROM A REVIEW OF THE SAVE TO DISK. THE FOLLOWING POINTS WERE NOTED FROM THE REVIEW. THE DEVICE WAS TAKEN OUT OF STORAGE ON 10-03-2008. IN 2009, THE DEVICE'S TACHY MODE WAS CHANGED DURING A PROCEDURE TO IMPLANT A LEFT VENTRICULAR (LV) LEAD FOR THE PATIENT. AS EXPECTED DAILY LV PACE IMPEDANCE AND LV INTRINSIC AMPLITUDE MEASUREMENTS STARTED TO OCCUR AFTER THAT DATE. AFTER THE PROCEDURE, DAILY RIGHT VENTRICULAR (RV) PACE IMPEDANCE MEASUREMENTS DROPPED FOR FOUR DAYS. THE R-WAVE INTRINSIC AMPLITUDE DAILY MEASUREMENTS WERE CONSISTENTLY AROUND 13 MILLI VOLTS UNTIL THE LAST EIGHT DAYS (STARTING FROM DATE OF PROCEDURE) WHERE THEY WERE REPORTED AS GREATER THAN 25 MILLI VOLTS. STORED EPISODES FROM V-10 TO V-14 REVEALED THAT THERE WAS MINIMAL OR NO INTRINSIC ACTIVITY NOTED ON THE ATRIAL CHANNEL. THERE WERE NO RESETS OR OTHER ABNORMAL MEMORY RELATED INDICATIONS NOTED FROM THE SAVE TO DISK. ENGINEERING'S REVIEW OF THE SAVE TO DISK AGREED WITH TS PREVIOUS REVIEW. THE DEVICE PROGRAMMING RESULTED IN DELAYED DETECTION AND THERAPY. HAD THE DEVICE BEEN PROGRAMMED OPTIMALLY, THE RATE WOULD NOT DETERIORATED TO THE POINT THAT WHEN IT WAS IN A THERAPY ZONE, THERAPY WAS INEFFECTIVE. TS PROVIDED PROGRAMMING SUGGESTIONS FOR FUTURE CASES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD EXPIRED. AN ALLEGATION WAS RECEIVED FROM A PHYSICIAN THAT THIS DEVICE DID NOT OPERATE CORRECTLY. IT WAS REPORTED THAT THE PATIENT INITIALLY EXPERIENCED A NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) IN WHICH THE RATE WAS BELOW THE RATE CUT-OFF OF 180. EVENTUALLY THE RATE WAS DETECTED; AND ANTI-TACHYCARDIA PACING (ATP) WAS ATTEMPTED; HOWEVER, THE MORPHOLOGY ON THE SHOCK CHANNEL HAD DETERIORATED SIGNIFICANTLY BY THE TIME ATP WAS DELIVERED, AND HAD NO AFFECT ON THE RHYTHM. SHOCK THERAPY WAS NEVER ATTEMPTED BY THE DEVICE. THE EXACT TIME OF THE PATIENT'S DEATH IS UNKNOWN. A TECHNICAL SERVICE (TS) CONSULTANT REVIEWED ELECTROGRAMS AND STATED THAT THE ELECTROGRAM GAIN WAS DIFFERENT BETWEEN THE EPISODES. THE UNDERSTANDING WAS LIKELY A RESULT OF THE BIG/SMALL PHENOMENON. TS RECOMMENDED FOR FUTURE SITUATIONS OR PATIENT'S THAT LOWERING THE ZONE WOULD HAVE BEEN APPROPRIATE PROGRAMMING AND THAT INCREASING SENSITIVITY DOES NOT CHANGE THE SPEED AT WHICH THE AUTO GAIN CONTROL (AGC) DRILLS DOWN TO THE FLOOR. A SAVE TO DISK WAS TO BE SENT IN FOR ANALYSIS. SUBSEQUENT INFORMATION INDICATED THAT THE PHYSICIAN STATED EVEN THOUGH THERE WAS POTENTIAL UNDERSENSING, THAT AT THAT TIME, HE/SHE DID NOT BELIEVE THAT WAS THE CAUSE OF THIS PATIENT'S DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death 4047| 4592| 0185| 4543| 4136| N119