BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILOS DR-T

    MDR report key: 1012590 · Received March 12, 2008

    Report

    Report Number
    1028232-2008-00219
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    January 9, 2008
    Report Date
    February 12, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PACEMAKER WAS EXPLANTED IN 2008, AFTER AN IMPLANTATION TIME OF 41 MONTHS BECAUSE OF AN INFECTION. THE BIOTRONIK STERILIZATION PROTOCOL CONFIRMED THAT ALL STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, ETC., WERE IN THEIR SPECIFIED RANGES. ALSO, THE INVESTIGATION OF THE MICROBIOLOGICAL INDICATORS SHOWED THE SUCCESSFUL COMPLETION OF THE STERILIZATION PROCESS. IN SUMMARY, THE INFECTION WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITHOUT OOS DOCUMENTATION FROM MEDTRONIC, INC. PER THE MEDTRONIC TECHNICAL SERVICES, THIS SYSTEM WAS REMOVED DUE TO INFECTION. THE SYSTEM WAS REPLACED WITH A MEDTRONIC SYSTEM. THERE ARE NO ADVERSE EVENTS REPORTED FOR THE PT. ALSO REMOVED: AEROX 60 BP, 1028232-2008-00220. AEROX 45 JBP, 1028232-2008-00221.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS DR-T PACEMAKER DXY BIOTRONIK GMBH AND CO 122544

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization