BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX

    MDR report key: 247513 · Received May 10, 1999

    Report

    Report Number
    2017865-1999-00481
    Event Type
    Malfunction
    Date Received
    May 10, 1999
    Date of Event
    February 19, 1999
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES THAT DURING A FOLLOW-UP, THE DEVICE SHOWED A LEAD IMPEDANCE OF >1990 OHMS. THE MEASURED DATA WAS 4.0V AMPLITUDE AND 0MA PULSE CURRENT. THE BATTERY MEASURED VALUES WERE 2.74V, 8UA AND <1K OHMS. WHEN THE DEVICE WAS PROGRAMMED TO A HIGHER OUTPUT, IMPEDANCE WAS NORMAL AT 770 OHMS. A LEAD REVISION WAS DONE THREE WEEKS PRIOR TO THE FOLLOW-UP, BUT THE ANOMALY REMAINED. THEREFORE THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX Implant IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2204L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention