BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR DR

    MDR report key: 4073677 · Received September 9, 2014

    Report

    Report Number
    2017865-2014-16689
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    July 14, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED BACKUP OPERATION. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2014, DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553553 ZEPHYR DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5820 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention