BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3212540 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08938
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    April 20, 2013
    Report Date
    May 29, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PATIENT WITH PACEMAKER HAS A HISTORY OF ATRIAL TACHYCARDIA, WITH LOW P-WAVE AMPLITUDES. THE PATIENT WAS SEEN IN THE HOSPITAL, PUT ON FLECAINIDE FOR ATRIAL ARRHYTHMIAS, AND AFTER THE MEDICATION WAS STARTED THE CAPTURE THRESHOLDS ROSE AND THE OUTPUTS WERE REPROGRAMMED ACCORDINGLY. THE HEALTH CARE PROFESSIONAL (HCP) NOTED THAT THE BATTERY GAUGE WAS AT BEGINNING OF LIFE (BOL), HOWEVER, THE REMAINING LONGEVITY ESTIMATE READ LESS THAN 0.5 YEARS. THE HEALTH CARE PROFESSIONAL (HCP) CONSULTED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND POTENTIAL REASONS FOR THIS OBSERVATION WERE DISCUSSED. THE PLAN WAS TO MONITOR THE PATIENT AND POTENTIALLY REPROGRAM THE DEVICE DEPENDING ON THE MEDICATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313720 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 4086| 4470| 4087| 1291