BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR MAX II

    MDR report key: 1875743 · Received October 20, 2010

    Report

    Report Number
    2124215-2010-20385
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    February 8, 2010
    Report Date
    August 26, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. IT WAS CONFIRMED THROUGH A REVIEW OF THE MEMORY THAT THE DEVICE WAS AT END OF LIFE (EOL) AND THERE WERE NO HARDWARE RESETS. THE DEVICE COMMUNICATED APPROPRIATELY WITH THE PROGRAMMER AND PACED AND SENSED NORMALLY. TO DETERMINE IF THE DEVICE HAD DEPLETED NORMALLY, A LABORATORY TECHNICIAN USED AN ENGINEERING LEVEL LONGEVITY PREDICTION CALCULATION TO ASSESS THE RATE OF BATTERY DEPLETION OF THE DEVICE. BASED ON THE AVAILABLE PARAMETERS, WE WOULD HAVE EXPECTED THE DEVICE TO LAST 81.6 MONTHS; HOWEVER, THE DEVICE WAS IMPLANTED 7.2 MONTHS LONGER THAN THIS. THE ZOOM PROGRAMMER LONGEVITY REMAINING INDICATOR HAS A RESOLUTION OF 0.5 YEARS. THIS MEANS IF THE ZOOM PROGRAMMER STATES 1 YEAR REMAINING LONGEVITY, IT IS ACTUALLY 1 YEAR OR LESS. THE DEVICE REACHING EOL WITHIN 10 MONTHS FROM THE LAST INTERROGATION WHEN THE LONGEVITY WAS ESTIMATED AT ONE YEAR FALLS WITHIN THIS ESTIMATED LONGEVITY TIMEFRAME. IN ADDITION, IT WAS NOTED THAT THE DEVICE HAD BEEN PROGRAMMED TO SSIR, INDICATING THAT THE RATE RESPONSE WAS "ON". SINCE RATE RESPONSE IS A DYNAMIC PACING OPTION AND THE LONGEVITY REMAINING IS A CALCULATION BASED ON PACING AMPLITUDE, PULSE WIDTH AND PACING RATE, THE LONGEVITY REMAINING CAN CHANGE IF THE PACING RATE INCREASES. WITH THIS FEATURE "ON", THE INCREASE DEMAND FOR A HIGHER PACING RATE MOST LIKELY RESULTED IN A HIGHER DRAIN ON THE BATTERY AND THUS REDUCING THE EXPECTED LONGEVITY FOR THIS DEVICE. HAVING EXCEEDED 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 BATTERY DEPLETION WITHIN THE NORMAL TOLERANCE FOR THIS MODEL BASED ON THE PROGRAMMED PARAMETERS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A NORMAL PATIENT FOLLOW UP, INTERROGATION OF THIS PACEMAKER REVEALED THAT IT HAD REACHED END OF LIFE (EOL).AT THE LAST FOLLOW UP LAST APRIL, THE REMAINING LONGEVITY WAS 1 YEAR. THERE IS A CONCERN THAT THE BATTERY DEPLETED EARLIER THAN EXPECTED AND THE PHYSICIAN WANTS TO KNOW WHY THE LONGEVITY ESTIMATE WAS NOT ACCURATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PACEMAKER WAS SUCCESSFULLY REPLACED AND LATER RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX II IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1180

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention