BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3911702 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-09603
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 18, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 FROM THE FIELD REPRESENTATIVE THAT THE PACEMAKER DISPLAYED SOME INTERESTING MARKERS AS SEEN ON THE PATIENT¿S STRIP. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE STRIP AND FOUND OUT THAT IT APPEARED TO HAVE SOME NOISE. IT IS DETERMINED THAT THE ISSUE UNLIKELY TO BE RELATED TO THE LEAD BUT POSSIBLY COULD BE AIR BUBBLES BASED ON ITS REGULAR PATTERN. ADDITIONAL INFORMATION REVEALED THE PHYSICIAN BELIEVED IT WAS AIR BUBBLES AND WAS RESOLVED OVERNIGHT. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391860 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K173

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR 5076| K173