BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 2781067 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13124
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 ONE MONTH POST-IMPLANT, THIS DEVICE WAS INDICATING THE BATTERY WAS A QUARTER OF THE WAY DEPLETED. THE PATIENT IS VENTRICULAR PACED 97 PERCENT OF THE TIME. AUTOMATIC CAPTURE WAS PROGRAMMED ON AND THE NEXT FOLLOW-UP APPOINTMENT WAS SCHEDULED FOR SIX MONTHS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K184

    Patients

    Seq Age Sex Outcome Treatment
    1