BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2153239 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06249
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS UNABLE TO BE INTERROGATED. A VISUAL INSPECTION OF THE DEVICE NOTED CRUSH MARKS AND SURFACE SCUFFING ACROSS THE PRINTED SURFACE OF THE DEVICE. DENTING AND SCRATCHES WERE ONLY PRESENT ON ONE SURFACE AND THE SIDES OF THE DEVICE. ANALYSIS CONCLUDED EXTENSIVE PHYSICAL DAMAGE WAS NOTED TO THE EXTERIOR OF THE DEVICE WHICH WAS CONSISTENT WITH INTERNAL DAMAGE. THIS COULD IMPACT THE RESULT FROM ANY ADDITIONAL TESTING; THEREFORE, NO FURTHER TESTING WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THISCARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS RETURNED FOR DISPOSAL AFTER EXPLANT. NO PRODUCT PERFORMANCE ALLEGATIONS OR ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED WITH REGARD TO THIS DEVICE. ROUTINE INITIAL RETURNED DEVICE TESTING INDICATED THAT DETAILED ANALYSIS WAS REQUIRED.

    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 80 YR 4517| H195| 4016| 0157| N118