BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR XL DR

    MDR report key: 1955897 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-01177
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 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
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND ELECTROCAUTERY MARKS ON THE PULSE GENERATOR CAN. THE DEVICE EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR WAS BEING EXPLANTED ELECTIVELY FOR AN UPGRADE TO A BIVENTRICULAR PACEMAKER. WHEN THE PHYSICIAN USED ELECTROCAUTERY TO OPEN THE POCKET, THE PULSE GENERATOR WENT TO NO OUTPUT. THE DEVICE DID NOT RESUME PACING AND THE PHYSICIAN HAD TO -SCRAMBLE- TO GET THE NEW DEVICE CONNECTED, AS THE PATIENT WAS PACEMAKER DEPENDENT.

    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 82 YR Required Intervention