BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3210848 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07060
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 26, 2013
    Report Date
    June 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. THE DEVICE FAULT CODE AND PREMATURE DEPLETION WERE CONFIRMED THROUGH ANALYSIS, HOWEVER THE ROOT CAUSE FOR THE HIGH CURRENT CONDITION THAT CAUSED THE PREMATURE DEPLETION AND FAULT CODE WAS INCONCLUSIVE.

    Additional Manufacturer Narrative · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT UPON INTERROGATION, THE DEVICE DISPLAYED A MESSAGE INDICATING THAT THE BATTERY VOLTAGE WAS TOO LOW FOR THE PROJECTED REMAINING LONGEVITY. IT WAS NOTED THAT THE DEVICE HAD DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) THREE MONTHS PRIOR TO THE INTERROGATION. AS A RESULT, A REVISION PROCEDURE WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310083 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR N119| 4096| 0185| 4549| 4555