BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2173093 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10583
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 13, 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 DEVICE 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP APPOINTMENT, IT WAS OBSERVED THAT THIS PATIENT, PROGRAMMED WITH AUTOMATIC CAPTURE ON, WAS PACING IN RETRY GREATER THAN 40 PERCENT OF THE TIME. THE PATIENT HAD BEEN HOSPITALIZED DUE TO AN ELECTROLYTE IMBALANCE, HOWEVER THIS HAS BEEN CORRECTED. THE DEVICE LONGEVITY WAS SHOWING 2.5 YEARS REMAINING SIX MONTHS AGO AND TODAY IS SHOWING LESS THAN 0.6 YEARS REMAINING. TECHNICAL SERVICES DISCUSSED WHY THE DEVICE WAS PACING IN RETRY FOR GREATER THAN 40 PERCENT OF THE TIME. 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 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 4464| 4055| 1290| 1280