BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR XL DR

    MDR report key: 4895747 · Received July 7, 2015

    Report

    Report Number
    3010215456-2015-27870
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 29, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC. (CRM-KISTA)
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED LOSS OF OUTPUT. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2015. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440701 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC. (CRM-KISTA) 5820 4690975

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention