BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3212382 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08700
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD AND DEVICE REMAINS 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 PROCEDURE, AFTER THE POCKET WAS CLOSED, NOISE WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD.THE NOISE WAS NOT SENSED BY THE PACEMAKER, BUT COULD BE REPRODUCED WITH POCKET MANIPULATION. A CONNECTION ISSUE WAS SUSPECTED. THE POCKET WAS REOPENED AND THE RA LEAD WAS REMOVED AND RECONNECTED TO THE DEVICE. THIS RESOLVED THE NOISE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313166 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K183

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 4088| 4087| K183