BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2052142 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03403
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 22, 2011
    Report Date
    April 11, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    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, THE RETURNED CRT-D WAS BELOW THE REPORTED BATTERY VOLTAGE, WHICH CAUSED THE DEVICE TO GENERATE A LOW BATTERY VOLTAGE FAULT. THE BEEP TONES WERE NOT CONFIRMED, HOWEVER DUE TO THE FAULT THE DEVICE WOULD NORMALLY BEEP. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. THIS DETAILED TESTING REVEALED DAMAGE TO THE DEVICE'S BYPASS BATTERY CAPACITOR. FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO A DAMAGED BYPASS CAPACITOR, WHICH RESULTED IN A HIGH CURRENT CONDITION.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE REOPENED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EMITTING BEEP TONES. THE PATIENT WAS BROUGHT INTO THE CLINIC AND THE DEVICE WAS INTERROGATED. UPON INTERROGATION A FAULT CODE DISPLAYED ALONG WITH A MESSAGE INDICATING "VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY." THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R 4046| H170| (B)(4)| 1861| N119| 0157| H177| (B)(4)| (B)(4)| 4470