BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR XL DR

    MDR report key: 4896145 · Received July 7, 2015

    Report

    Report Number
    2017865-2015-26698
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 28, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED INAPPROPRIATE MEASURED DATA. THE DEVICE WAS EXPLANTED. NO ADVERSE CONSEQUENCES OCCURRED TO THE PATIENT. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438890 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5826 2914299

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention