BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1946218 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-23824
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 14, 2010
    Report Date
    May 17, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT BEEN RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION, BUT VARIANCE OF BATTERY STATUS WAS OBSERVED. DECLARATION OF ERT OCCURS AFTER THE DEVICE COMPLETES AN INTERNAL CALCULATION OF BATTERY CONSUMPTION. FACTORS INFLUENCING THIS CALCULATION INCLUDE PACING RATE, AMPLITUDE, PULSE-WIDTH, LEAD IMPEDANCE, AND THE LAST 30 DAYS AVERAGE PACING PERCENTAGE. ANY CHANGES IN THOSE FACTORS WILL IMPACT THE BATTERY CONSUMPTION CALCULATION. THE ESTIMATED LONGEVITY REMAINING AND BATTERY STATUS GAUGE DISPLAYED BY THE PROGRAMMER ARE BASED ON BATTERY CURRENT CONSUMPTION CALCULATIONS AT THE TIME OF INTERROGATION, AND CALCULATIONS PERFORMED INTERNAL TO THE DEVICE ARE SUSPENDED DURING THE SESSION. WHEN AMBULATORY (AWAY FROM THE PROGRAMMER), THE DEVICE PERIODICALLY ASSESSES OPERATING CURRENT AND MAY REVISE THE ERT DECLARATION POINT TO ENSURE A MINIMUM OF 3 MONTHS BATTERY LIFE BETWEEN ERT AND EOL. THIS DEVICE ASSESSMENT OF OPERATING CURRENT, BATTERY CHARGE STATE, AND REVISION OF THE ERT DECLARATION POINT MAY CAUSE DIFFERENCES AND FLUCTUATIONS RELATIVE TO PREVIOUS PROGRAMMER BATTERY STATUS INDICATORS. DETAILED MECHANICAL AND ELECTRICAL TESTING WAS PERFORMED. THE DEVICE FUNCTIONED NORMALLY THROUGHOUT TESTING. ANALYSIS CONCLUDED THIS DEVICE DID NOT EXPERIENCE A COMPONENT MALFUNCTION OR PREMATURE BATTERY DEPLETION, AND REPLACEMENT INDICATORS WERE DISPLAYED APPROPRIATELY, RELATIVE TO THE ACTUAL BATTERY CONDITION. HOWEVER, SERVICE LIFE FELL SLIGHTLY SHORT OF LONGEVITY EXPECTATIONS AS DEPICTED IN THE INSTRUCTIONS FOR USE THAT WERE ORIGINALLY APPROVED AND DISTRIBUTED WITH THIS DEVICE. LONGEVITY ESTIMATION TOOLS HAVE SINCE BEEN REFINED TO BETTER REFLECT ACTUAL DEVICE PERFORMANCE AND CURRENT CLINICAL PRACTICES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER'S BATTERY LONGEVITY DECREASED FROM 1.5 YEARS REMAINING TO LESS THAN 0.5 YEARS REMAINING AFTER THE DEVICE WAS TESTED AND NO PROGRAMMING CHANGES MADE. A MEMORY DOWNLOAD REVEALED A SMALL CHANGE IN RIGHT ATRIAL (RA) IMPEDANCE MEASUREMENTS CAUSED THE THE CURRENT DRAIN ON THE BATTERY TO INCREASE WHICH DECREASED ESTIMATED LONGEVITY REMAINING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE BATTERY STATUS OF THIS DEVICE CONTINUED TO VARY AND THE MAGNET RATE CHANGED FROM 90 PPM TO 100 PPM AND BACK TO 90 PPM. THIS PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO BEING AT END OF LIFE (EOL) FOR A COUPLE MONTHS. THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT BECAUSE OF THE VARIANCE OF BATTERY STATUS, THEY WERE NOT ABLE TO ESTIMATE HOW MUCH TIME WAS LEFT ON BATTERY BEFORE IT REACHED EOL. THIS DEVICE WAS EXPLANTED AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention 4086| 4087| 1298