BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3050049 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03367
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 DURING THE IMPLANT OF THIS PACEMAKER WITH ANOTHER MANUFACTURER'S RIGHT VENTRICULAR (RV) LEAD, A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT WAS OBSERVED. THE LEAD WAS REMOVED FROM THE DEVICE HEADER AND REINSERTED AND ACCEPTABLE MEASUREMENTS WERE OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153194 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 4076| K173