BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2170339 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09807
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    September 18, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY CONFIRMED THAT A LOW VOLTAGE BATTERY FAULT CODE (FAULT CODE 1003) HAD BEEN RECORDED ON (B)(4) 2012. A SERIES OF AUTOMATED ELECTRICAL/FUNCTIONAL TESTS WERE CONDUCTED AND NO ISSUES WITH DEVICE PERFORMANCE WERE OBSERVED; BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE WERE VERIFIED. THE DEVICE CASE WAS OPENED TO FACILITATE ANALYSIS OF THE INTERNAL COMPONENTS. THE BATTERY WAS SEPARATED FROM THE OTHER ELECTRONICS AND THE OVERALL CURRENT DRAW OF THE DEVICE CIRCUITRY WAS MEASURED. THE MEASURED CURRENT DRAIN WAS NOT AS EXPECTED. IN-DEPTH DESTRUCTIVE ANALYSIS OF THE BATTERY ITSELF REVEALED EVIDENCE OF A LATENT INTERNAL ELECTRICAL SHORT BETWEEN ONE OF THE ANODE AND CATHODE LAYERS WITHIN THE BATTERY. THIS SHORT WAS RESPONSIBLE FOR THE ACCELERATED DEPLETION OF THE BATTERY.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THIS DEVICE SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS INVESTIGATION WILL BE REOPENED AND UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UPON FURTHER ANALYSIS, ENGINEERS DETERMINED THE ISSUE WAS NOT WITH THE BATTERY ITSELF, RATHER AN ANOMALY WITHIN THE DEVICE'S INTERNAL CIRCUITRY. ENGINEERS NOTED THIS TYPE OF ANOMALY WOULD NOT CAUSE A HIGH CURRENT TO OCCUR WITHIN THE DEVICE. FINAL ANALYSIS WAS UNABLE TO DETERMINE THE CAUSE FOR THE PREMATURE BATTERY DEPLETION AS THE DEVICE FUNCTIONED NORMALLY DURING TESTING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT DURING A RECENT INTERROGATION OF THIS DEVICE A YELLOW WARNING POPPED UP ON THE PROGRAMMER WITH AN ERROR CODE OF FC 1003 - STATING THE VOLTAGE IS TO LOW FOR REMAINING CAPACITY. THE DEVICE ALSO CONTINUED TO SHOW NOISE WHICH RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) OCCURRING AT RANDOM TIMES OF THE DAY. ALL OTHER MEASUREMENTS ARE WITHIN NORMAL RANGE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED A MEMORY SAVE TO DISK BE PERFORMED AND SENT IN FOR ANALYSIS. THE DISK WAS SENT IN AND SHOWED A LOW VOLTAGE FAULT, THE DEVICE APPEARS TO HAVE IRREGULAR PERIODS OF RAPID DISCHARGE, AND THE BATTERY VOLTAGE IS DROPPING VERY FAST AND IS NEAR ELECTIVE REPLACEMENT INDICATOR (ERI) LEVELS. TS SUGGESTED THAT BASED ON THE CURRENT RATE OF VOLTAGE DROP, IT APPEARS THAT THE DEVICE SHOULD BE ABLE TO SUPPORT THERAPY FUNCTIONS FOR MORE THAN A WEEK. HOWEVER, IT IS RECOMMENDED THAT THE UNIT BE REPLACED AS SOON AS POSSIBLE DUE TO THE IRREGULAR BEHAVIOR OF THE DEPLETION. THE DEVICE HAS SINCE BEEN EXPLANTED AND SUCCESSFULLY REPLACED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED SEVERAL EPISODES OF NOISE WHICH LED TO PAUSES IN PACING FOR GREATER THAN 2 SECONDS. THE NOISE EPISODE CAUSED SOME INAPPROPRIATE EPISODES OF ANTI TACHYCARDIA PACING (ATP) AND ALL HAD OCCURRED IN THE MIDDLE OF THE NIGHT. IT IS BELIEVED THAT THE PATIENT SNORING WHILE SLEEPING MIGHT BE THE CAUSE OF THE NOISE. ALL LEAD DIAGNOSTICS ARE NORMAL AND THE DEVICE REMAINS IMPLANTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| O 4470| 4517| N118| 0185