BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2042303 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02993
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY CONFIRMED THAT THE DEVICE WAS OPERATING IN FALLBACK MODE. DETAILED ANALYSIS FOUND THAT DEVICE DIAGNOSTICS BUILT INTO THE DEVICE DETECTED UNEXPECTED CHANGES IN CERTAIN LOCATIONS OF DEVICE MEMORY. A DESIGNED PRECAUTIONARY RESPONSE BY THE DEVICE RESULTED IN A CHANGE TO A WELL-DEFINED "SAFE" DEFAULT MODE WHICH OPERATES AS A SINGLE-ZONE ICD WITH LIMITED PROGRAMMABILITY AND SHOCKING CAPABILITY. THE CAUSE OF THE MALFUNCTION WAS CONCLUDED TO BE A RESULT OF SOFTWARE CORRUPTION INDUCED BY RADIATION THERAPY. BOSTON SCIENTIFIC DOES NOT HAVE A SPECIFICATION FOR ANY OF ITS PRODUCTS THAT DEFINES THE MAXIMUM AMOUNT OF RADIATION THAT THE DEVICE CAN RECEIVE BEFORE PROPER DEVICE FUNCTION CAN NO LONGER BE GUARANTEED. THE PRODUCT MANUAL SHIPPED WITH EACH DEVICE STATES THAT THERAPEUTIC RADIATION IS A POTENTIAL HAZARD FOR THOSE PATIENTS THAT HAVE RECEIVED OUR IMPLANTABLE PACEMAKER OR DEFIBRILLATORS. AS THERE IS THE POTENTIAL FOR DEVICE MEMORY ALTERATIONS, WE RECOMMEND VERIFYING DEVICE OPERATION FOLLOWING DELIVERY OF RADIATION THERAPY. WE CAN PROVIDE INSTRUCTIONS REGARDING SHIELDING AND DOSAGE IN AN EFFORT TO REDUCE THE LIKELIHOOD OF DEVICE DAMAGE, AND CAN RECOMMEND TEST PROCEDURES FOLLOWING RADIATION APPLICATION TO VERIFY APPROPRIATE DEVICE FUNCTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT UPON INTERROGATION, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DISPLAYED A WARNING MESSAGE STATING 'ONE SINGLE ZONE - PACING NON PROGRAMMABLE'. IN ADDITION, THE PATIENT HAD BEEN RECEIVING RADIATION THERAPY FOR PROSTATIC CANCER. A BOSTON SCIENTIFIC TECHNICAL CONSULTANT WAS CONTACTED AND DISCUSSED THAT THE DEVICE SOFTWARE HAD DETECTED A MEMORY FAILURE THAT COULD NOT BE CORRECTED. THE DEVICE FUNCTIONALITY HAD REVERTED TO A "FALLBACK" MODE WITH LIMITED FUNCTIONALITY. THE DEVICE WILL EMIT PATIENT WARNING TONES. THE FALLBACK VALUES WILL RESULT IN VF THERAPY WITH 5 MAXIMUM ENERGY SHOCKS (ALL COMMITTED). THE MOST LIKELY HYPOTHESIS WAS THAT RADIATIONS INTERFERED WITH THE IMPLANTED DEVICE. IT WAS RECOMMENDED TO PROGRAM THE FALLBACK MODE AS APPROPRIATE (REGARDING AVAILABLE PROGRAMMABLE SETTINGS) AND SCHEDULE THE PATIENT FOR DEVICE REPLACEMENT. AS THE PATIENT HAS TO CONTINUE RADIOTHERAPY 15 MORE TIMES; THE PATIENT'S PHYSICIAN WAS TO DETERMINE IF THE DEVICE AS TO BE REPLACED IN THE NEAR FUTURE OR AT THE END OF THE RADIOTHERAPY SESSIONS BASED ON PATIENT CONDITION, TACHY/BRADY HISTORY, AND BATTERY STATUS. ADDITIONAL INFORMATION WAS RECEIVED; ON (B)(6) 2011 THE DEVICE WAS REMOVED, REPLACED, AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1870

    Patients

    Seq Age Sex Outcome Treatment
    1 Other