BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AROX 45 JEP

    MDR report key: 1436082 · Received May 6, 2009

    Report

    Report Number
    1028232-2009-00588
    Event Type
    Malfunction
    Date Received
    May 6, 2009
    Date of Event
    March 31, 2009
    Report Date
    April 13, 2009
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    K021217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    PER OOS, THIS LEAD WAS CAPPED. PER FACILITY, THIS LEAD WAS CAPPED DUE TO HIGH THRESHOLDS. THIS LEAD WAS REPLACED WITH AN ACTIVE FIXATION SETROX S 45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AROX 45 JEP PACER LEAD DTB BIOTRONIK GMBH AND CO. 338022

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization