BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 60

    MDR report key: 3952912 · Received July 23, 2014

    Report

    Report Number
    1028232-2014-002520
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 15, 2014
    Report Date
    July 14, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INFECTION WAS OBSERVED FOLLOWING THE IMPLANTATION OF THIS BIOTRONIK DEVICE. THE STERILIZATION PROCESS WAS INVESTIGATED. THE VALIDATED PROCESS ASSURES THAT ALL STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, ETC., ARE WITHIN ITS SPECIFIED RANGES FOR EACH DISTRIBUTED DEVICE. ADDITIONAL AN ANALYSIS OF VALIDATED MICROBIOLOGICAL INDICATORS IS PERFORMED AFTER EVERY STERILIZATION PROCEDURE AS EVIDENCE OF SUCCESSFUL COMPLETION OF THE STERILIZATION PROCESS. REVIEW OF THE BIOTRONIK COMPLAINT DATABASE DID NOT REVEAL ANY CHANGES REGARDING THE TREND FOR THIS TYPE OF INCIDENT. IN SUMMARY, THE INFECTION WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    THIS SYSTEM WAS REMOVED DUE TO ENDOCARDITIS. THE HOSPITAL RETAINED THE DEVICES. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430265 SETROX S 60 PACER LEAD NVN BIOTRONIK SE & CO. KG 350975

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization