BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2041794 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01956
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 14, 2011
    Report Date
    March 30, 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

    THE PACEMAKER REMAINS IMPLANTED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION, BUT DECLARED END OF LIFE (EOL) EARLIER THAN PREVIOUSLY ESTIMATED. DECLARATION OF THIS INDICATOR 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 ELECTIVE REPLACEMENT TIME (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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER DISPLAYED A MAGNET RATE OF 100, A BATTERY GAUGE OF 1/4 AND 1.5 YEARS LONGEVITY REMAINING. THE ATRIAL SENSITIVITY OF THE DEVICE WAS REPROGRAMMED. ONE MONTH LATER THE DEVICE DISPLAYED A MAGNET RATE OF 100PPM AGAIN. THREE MONTHS LATER THE PACEMAKER MAGNET RATE WAS 85PPM DURING TRANSTELEPHONIC MONITORING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    OUR COMPANY RECEIVED ADDITIONAL INFORMATION THAT WHEN THE PATIENT WAS SEEN IN THE CLINIC, THE DEVICE HAD REACHED END OF LIFE. THE CLINIC HAD NEVER RECEIVED A MAGNET RATE OF 90 AND THEREFORE HAD NOT INTENSIFIED THE PATIENT'S FOLLOW-UP. THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. THE PHYSICIAN AND PATIENT DECIDED NOT TO REPLACE THE DEVICE. 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 87 YR 4087| 1298| 4086