BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2905501 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-14471
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 2, 2012
    Report Date
    January 18, 2013
    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 POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PRODUCT WAS PERFORMED. ENGINEERING CALCULATIONS CONFIRMED THE LONGEVITY OF THIS DEVICE WAS NOT AS EXPECTED. THE DEVICE CASE WAS OPENED. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE DEVICE AND THE ELECTRICAL CURRENT WAS MONITORED. DURING THE MONITORING PROCESS A HIGH CURRENT CONDITION WAS OBSERVED. ELECTRICAL TESTING AND ANALYSIS WERE THEN CONDUCTED, WHICH ISOLATED THE HIGH CURRENT TO AN ANOMALY IN AN OXIDE LAYER WITHIN AN INTEGRATED CIRCUIT. THIS ANOMALY CAUSES A HIGH CURRENT DRAIN, WHICH OVER TIME RESULTED IN THE PREMATURE BATTERY DEPLETION OBSERVATION.

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT DUE TO PREMATURE BATTERY DEPLETION, A REVISION PROCEDURE WAS PERFORMED AND THIS DEVICE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO ALLOW FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP APPOINTMENT, DEVICE LONGEVITY WAS SEVEN AND A HALF (7.5) YEARS. LEFT VENTRICULAR OUTPUTS HAD BEEN INCREASED BY 1.0V. APPROXIMATELY THREE MONTHS LATER, REMAINING DEVICE LONGEVITY WAS LESS THAN ONE YEAR. TECHNICAL SERVICES WAS CONSULTED AND DISCUSSED THE EXCESSIVE POWER CONSUMPTION AND THE URGENCY OF REPLACING THE DEVICE DUE TO PATIENT PACER DEPENDENCE. NO DEVICE ALLEGATIONS WERE NOTED. A SAVE TO MEMORY DISK WAS PERFORMED. ANALYSIS CONFIRMED THAT THE DELIVERED THERAPY WAS A RESULT OF THE INCREASED POWER AND THE DEVICE WAS UNDERGOING A HARDWARE MALFUNCTION. DETAILED ANALYSIS WAS RECOMMENDED ONCE THE DEVICE WAS EXPLANTED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10775 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR H170| 4086| 4538| N119| H210| 0157