BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1873812 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17688
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    December 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    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, LABORATORY TECHNICIANS UTILIZED AN ENGINEERING LEVEL LONGEVITY PREDICTION CALCULATION TO ASSESS THE RATE OF BATTERY DEPLETION, GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE. THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. NEXT, A COMPREHENSIVE SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES DISCUSSED THAT LABELING RECOMMENDS DEVICE REPLACEMENT WITHIN 90 DAYS OF ERI. SINCE ERI WAS DECLARED BASED ON CHARGE TIME AND NOT MONITORING VOLTAGE, THE DEVICE WOULD LIKELY BE ABLE TO PROVIDE THERAPY FOR LONGER THAN 90 DAYS, BUT THE CHARGE TIME FOR THERAPY DELIVERY COULD BE GREATER THAN 25 SECONDS IF A SHOCK WAS NEEDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

    Additional Manufacturer Narrative · 1

    THE FIELD REPRESENTATIVE LATER REPORTED THAT THE DEVICE HAD DECLARED END OF LIFE (EOL) BATTERY STATUS WITH A MONITORING VOLTAGE OF 2.57V AND A CHARGE TIME OF 31.5 SECONDS. TECHNICAL SERVICES DISCUSSED THERAPY AVAILABILITY AT EOL, THAT THE DEVICE WOULD CONTINUE TO PROVIDE THERAPY BUT THE CHARGE TIMES WOULD BE LONG. IT WAS NOTED THAT THE PATIENT REMAINED IN THE HOSPITAL WITH OTHER MEDICAL CONCERNS. THE DEVICE WAS REPLACED APPROXIMATELY TWO MONTHS AFTER EOL WAS DECLARED. THERE WERE NO FURTHER ALLEGATIONS AGAINST THE DEVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED DEVICE WAS RETURNED AND IS UNDERGOING LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS EARLIER THAN EXPECTED. THE MONITORING VOLTAGE WAS 2.58V AND THE CHARGE TIME WAS 25.1 SECONDS. THE CLINICIAN REQUESTED AN ESTIMATE OF REMAINING LONGEVITY, AS THE PHYSICIAN WANTED TO WAIT TO PERFORM THE DEVICE REPLACEMENT AFTER THE PATIENT'S OTHER MEDICAL ISSUES WERE RESOLVED. DEVICE REACHED ERI ON (B)(6) 2010 AND DR ASKED CALLER TO FIND OUT EXPECTED LONGEVITY REMAINING. CALLER SAID THAT PATIENT HAS OTHER HEALTH-RELATED AND THEY'D LIKE TO WAIT UNTIL THEY CLEAR UP SINCE PATIENT IS AT RISK OF INFECTION RIGHT NOW. TS ASKED FOR BATTERY INFO AND VOLTAGE WAS 2.58 WITH CT IS 25.1 SEC (LAST DELIVERED SHOCK 11.5 SEC). DISCUSSED HOW DEVICE DECLARED ERI BASED ON CT AND THAT WHEN ERI IS DECLARED LABELED RECOMMENDATIONS FOR REPLACEMENT WOULD BE 3 MO'S. DISCUSSED HOW THIS DEVICE MIGHT HAVE MORE THAN THAT BASED ON VOLTAGE BUT IT COULD TAKE > 25 SEC FOR DEVICE TO DELIVER MAX ENERGY SHOCK AND THIS WOULD NEED TO BE CONSIDERED ALONG WITH PATIENT'S OTHER HEALTH CONDITIONS.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention T175| 0185