BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR DR

    MDR report key: 4073638 · Received September 9, 2014

    Report

    Report Number
    2017865-2014-16695
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    June 13, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553922 ZEPHYR DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5820 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention