BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1342014 · Received March 3, 2009

    Report

    Report Number
    2124215-2009-04167
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    June 29, 2006
    Report Date
    March 4, 2009
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NKE
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO Z-1055-2007. GUIDANT'S RELIABILITY ASSURANCE LAB CONFIRMED THAT THE DEVICE WAS OPERATING IN SAFETY MODE. DETAILED ANALYSIS FOUND THAT BUILT-IN DEVICE DIAGNOSTICS DETECTED UNEXPECTED CHANGES IN CERTAIN LOCATIONS OF DEVICE MEMORY, WHICH WERE NOT CORRECTABLE. A DESIGNED PRECAUTIONARY RESPONSE BY THE DEVICE RESULTED IN A CHANGE TO A WELL-DEFINED "SAFE" MODE WHICH OPERATES AS A SINGLE-ZONE ICD WITH LIMITED PROGRAMMABILITY AND SHOCKING CAPABILITY, AND WOULD HAVE PROTECTED THE PT IN CASE OF AN ARRHYTHMIA. ADDITIONALLY, NON-PROGRAMMABLE VVI PACING AT 60PPM IS AVAILABLE. THE CAUSE OF THE MALFUNCTION WAS CONCLUDED TO BE A RESULT OF SOFTWARE CORRUPTION INDUCED BY RADIATION THERAPY. DEVICE PERFORMANCE FOLLOWING RADIATION EXPOSURE IS DISCUSSED IN PRODUCT LABELING. THE MEMORY PUMP FROM THIS DEVICE WAS RETRIEVED FROM ELECTRONIC STORAGE FOR FURTHER TESTING IN 2007. THE DEVICE'S STORED MEMORY WAS REVIEWED AND EVALUATED BY BOSTON SCIENTIFIC'S RELIABILITY ASSURANCE LABORATORY. DETAILED ANALYSIS FOUND THAT BUILT-IN DEVICE SELF-DIAGNOSTICS DETECTED UNEXPECTED CHANGES IN CERTAIN LOCATIONS OF DEVICE MEMORY THAT CONTROLS EPISODE DATA. IN RESPONSE TO THIS, THE DEVICE INITIATED A WARM RESET IN AN ATTEMPT TO CORRECT THIS PROBLEM. THE PROCESSING PERFORMED DURING THIS WARM RESET WAS APPROPRIATELY EXECUTED, HOWEVER, A FIRMWARE DESIGN ISSUE PREVENTED THE DEVICE FROM FURTHER UPDATING DATA VARIABLES STORED IN THIS AREA OF MEMORY. THIS FINDING HAS BEEN CLASSIFIED AS NON-CLINICALLY OUT-OF SPEC AND WOULD NOT HAVE IMPACTED THIS DEVICE'S ABILITY TO SENSE AND DELIVER THERAPY GIVEN THIS PT'S EPISODE HISTORY AND THE DEVICE'S EXPLANT DATE. THIS MDR REPORT WILL BE CONSIDERED LATE. THIS EVENT IS BEING MDR REPORTED BASED ON A PRECEDENT EVENT WHICH WAS REPORTED DUE TO THE IDENTIFIED FAILURE MECHANISM, THEREFORE, EVENTS IN THIS TREND CATEGORIZED AS YELLOW OR RED MEET THE CRITERIA FOR REPORTABILITY.

    Description of Event or Problem · 1

    GUIDANT (NOW BOSTON SCIENTIFIC CORP) RECEIVED INFO THAT THIS IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A RED SCREEN WARNING INDICATING THE DEVICE HAD REVERTED TO SAFETY MODE, WHEREBY SINGLE ZONE SHOCK AND VVI PACING THERAPIES REMAIN AVAILABLE. FURTHER DISCUSSIONS WITH THE FIELD IDENTIFIED THAT THE PT HAD BEEN UNDERGOING RADIATION TREATMENT FOR ESOPHAGEAL CANCER. A GUIDANT TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED REPLACEMENT OF THE DEVICE ONCE THE RADIATION TREATMENTS HAD BEEN COMPLETED. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND RETURNED TO GUIDANT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NKE GUIDANT CRM CLONMEL IRELAND H170

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR