BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILESTO 7 VR-T DX PROMRI DF-1

    MDR report key: 5538668 · Received March 31, 2016

    Report

    Report Number
    1028232-2016-01027
    Event Type
    Injury
    Date Received
    March 31, 2016
    Date of Event
    January 25, 2016
    Report Date
    March 14, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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. ADDITIONALLY 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

    OUS MDR - THE PATIENT SUFFERED FROM HYPERPYREXIA. STAPHYLOCOCCUS SEPSIS WAS DIAGNOSED. THE PATIENT WAS HOSPITALIZED WITH ANTIBIOTIC THERAPY. E. COLI WAS ISOLATED WITH A URINE CULTURE TEST AND STAPHYLOCOCCUS AUREUS WITH A MICROBIOLOGICAL CULTURE OF BLOOD. UPDATE 10. MRZ 2016: EVENT DATE: (B)(6) 2016 THE PATIENT FELL DOWN, BUT WAS NOT UNCONSCIOUS, AND SUFFERED FROM HYPERPYREXIA. STAPHYLOCOCCUS SEPSIS WAS DIAGNOSED AGAIN. THE PATIENT ALREADY SUFFERED FROM STAPHYLOCOCCUS SEPSIS ONE MONTH BEFORE. THE PATIENT WAS HOSPITALIZED, AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194006 ILESTO 7 VR-T DX PROMRI DF-1 ICD LWS BIOTRONIK SE & CO. KG 390094

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization