BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3038791 · Received April 5, 2013

    Report

    Report Number
    2124215-2013-04701
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    November 23, 2012
    Report Date
    February 13, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THE PATIENT IMPLANTED WITH THIS DEVICE REPORTED A HEART RATE BELOW THE LOWER RATE LIMIT (LRL) ESPECIALLY AT NIGHT AND EARLY MORNING. THE LOCAL AREA REPRESENTATIVE CONFIRMED THAT SINCE THIS ALLEGATION THE PATIENT WAS SEEN IN CLINIC FOR A NORMAL DEVICE FOLLOW UP. THE DEVICE WAS CHECKED AND IT WAS CONFIRMED THAT THE DEVICE NEVER FELL BELOW THE LRL. SINCE THAT OFFICE VISIT THE PATIENT AGAIN ALLEGED THAT THEIR HEART RATE WAS BELOW THE LRL. THEY ALSO ALLEGED HEARING TONES AND BEING SHORT OF BREATH. A COMPANY REPRESENTATIVE DISCUSSED THE DEVICE WILL NEVER MAKE AN AUDIBLE SOUND LIKE A BEEP AND ADVISED TO NOTIFY THE PHYSICIAN IF THE PATIENT CAN HEAR TONES, VIBRATIONS, GROWLS AND ETC. ADDITIONAL INFORMATION FROM THE LOCAL FIELD REPRESENTATIVE INDICATES THAT THE PATIENT HAS NOT BEEN SEEN IN CLINIC SINCE THEIR LAST REGULARLY SCHEDULED FOLLOW UP APPOINTMENT. THE PATIENT HAS NOT CONTACTED THEIR PHYSICIAN TO REPORT ANY DEVICE ISSUES. AS OF TODAY THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140833 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K062

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR K062| 4471