BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR MAX II

    MDR report key: 2172944 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10124
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 8, 2011
    Report Date
    October 25, 2011
    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

    TECHNICAL SERVICES DISCUSSED POSSIBLE CAUSES AND ADVISED FURTHER INVESTIGATION OF POSSIBLE RADIATION EXPOSURE AND RECOMMENDED A MEMORY ANALYSIS OF THIS DEVICE. THIS WAS TO BE FURTHER DISCUSSED WITH THE PHYSICIAN. ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCT REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, REVIEW OF DEVICE MEMORY IDENTIFIED A RESET HAD OCCURRED WHILE THIS DEVICE WAS IMPLANTED. ADDITIONALLY, IT WAS NOTED THE DEVICE HAD BEEN PROGRAMMED WITH ATRIAL FLUTTER RESPONSE (AFR) ON. WHEN AFR IS PROGRAMMED ON IN THIS FAMILY OF DEVICES AND OTHER UNCOMMON PARAMETERS ARE ALSO PROGRAMMED, THIS MAY RESULT IN THE TYPE OF RESET OBSERVED DURING LABORATORY ANALYSIS. NEWER GENERATION DEVICES ARE MANUFACTURED SUCH THAT THIS TYPE OF INTERACTION SHOULD NOT OCCUR.

    Additional Manufacturer Narrative · 1

    THE REPRESENTATIVE FURTHER REPORTED THAT THE PATIENT STATED THAT THEY HAD NOT BEEN EXPOSED TO RADIATION OR ANY OTHER TREATMENTS. A SAVE TO DISK WAS NOT PERFORMED DUE TO TIME CONSTRAINTS AND THE CLINIC WILL CONTINUE TO OBSERVE THE DEVICE THROUGH A NORMAL FOLLOW UP ROUTINE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DAILY MEASUREMENTS WERE MISSING FROM THE LOGBOOK OF THIS PACEMAKER FOR THE PAST YEAR. IN ADDITION, LOW ATRIAL AMPLITUDES WERE ALSO REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX II IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1280

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 1280| 4451| 4476| 4473| 1283