BEUDAMED
    FDA Adverse Event Other Summary report: N

    AROX 53-JBP

    MDR report key: 731205 · Received June 29, 2006

    Report

    Report Number
    1028232-2006-00095
    Event Type
    Other
    Date Received
    June 29, 2006
    Date of Event
    May 24, 2005
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DTB
    PMA / PMN Number
    k021217
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AN INTERNAL REVIEW REVEALED THAT THIS PRODUCT WAS REMOVED FOR INFECTION AND DISCARDED BY THE HOSPITAL. THIS DEVICE WAS PART OF A SYSTEM REMOVED FOR INFECTION. PLEASE REFERENCE MDR# 04-0080 FOR ADDITIONAL INFORMATION. A NEW SYSTEM WAS IMPLANTED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AROX 53-JBP BRADYCARDIA LEAD DTB BIOTRONIK GMBH AND CO 338 025 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization