BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3043242 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-04369
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PROGRAMMING CHANGES WERE MADE. AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IMPLANTED AND 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 THIS PACEMAKER AND ANOTHER MANUFACTURER'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED POTENTIAL T-WAVE OVERSENSING ON HOLTER MONITORING RESULTING IN PACING INHIBITION FOR GREATER THAN TWO SECONDS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE STRIPS AND DISCUSSED TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147086 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S401

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR 5076| 1184| S401