BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA ULTRA

    MDR report key: 659513 · Received November 14, 2005

    Report

    Report Number
    2124215-2005-10979
    Event Type
    Malfunction
    Date Received
    November 14, 2005
    Date of Event
    August 5, 2005
    Report Date
    August 5, 2005
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT OND DAY POST IMPLANT THIS DEVICE COULD NOT BE INTERROGATED. IT WAS NOTED THAT THE CLINICIAN WAS UNAWARE OF THE DEVICE TYPE AT THE TIME OF ATTEMPTING TO INTERROGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA ULTRA IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS 1291 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other