BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR XL DR

    MDR report key: 1896203 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05351
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 3, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THAT THE PULSE GENERATOR EXHIBITED HIGH CURRENT DRAIN DUE TO A LEAKY CAPACITOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED A SHORT LONGEVITY PROJECTION; (B)(4) . THE DEVICE IMAGE SHOWED LOW IMPEDANCES, VARYING FROM 0.135 OHMS TO 0.0006 OHMS, DESPITE THE HIGH CURRENT DRAIN. THE PULSE GENERATOR WAS EXPLANTED AND REPLACED.

    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 85 YR Required Intervention (B)(4)