BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1945719 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20397
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 11, 2010
    Report Date
    May 16, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THIS ICD REVEALED NO ANOMALIES. ATTEMPTS TO INTERROGATE THE DEVICE WERE UNSUCCESSFUL. THE DEVICE CASE WAS OPENED IN ORDER FOR THE INTERNAL COMPONENTS TO BE ASSESSED. DETAILED ANALYSIS DETERMINED THE INABILITY TO INTERROGATE THIS DEVICE WAS DUE TO AN INTERNAL SHORT WITHIN THE TRANSFORMER WHICH RESULTED IN DAMAGE THROUGHOUT INTERNAL CIRCUITRY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) WAS NOT ABLE TO BE INTERROGATED. APPLICATION OF A MAGNET DID NOT PRODUCE TONES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATED THAT THE DEVICE WAS NEVER ABLE TO BE INTERROGATED. A REPLACEMENT PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS.

    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 48 YR Required Intervention 4543| N119| 5076| 4074| MISMATCH| 0184