BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3210222 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09879
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A PACEMAKER DEVICE CHECK FOR THIS PACER DEPENDENT PATIENT, THE FIELD REPRESENTATIVE REPORTED SEEING ATRIAL ACTIVITY BEING OVERSENSED ON THIS RIGHT VENTRICULAR (RV) LEAD, CAUSING RV PACING TO BE INHIBITED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND NO FURTHER INFORMATION COULD BE OBTAINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308946 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4087| 1291