BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 1896205 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05357
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    August 9, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED INTER- MITTENT CAPTURE AND PACING. NOISE WAS OBSERVED ON THE EGM IN THE VENTRICULAR SENSING AMPLITUDE CONFIGURATION. IN THE BIPOLAR CONFIGURATION, NOISE WAS OBSERVED ON ALL BIPOLAR, UNIPOLAR TIP AND UNIPOLAR RING SETTINGS. THE DEVICE WAS EX- POSED TO ELECTROCAUTERY. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5826 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention