BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPERIA 7 DR-T DF4 PROMRI

    MDR report key: 6693618 · Received July 7, 2017

    Report

    Report Number
    1028232-2017-02330
    Event Type
    Injury
    Date Received
    July 7, 2017
    Date of Event
    June 30, 2017
    Report Date
    July 3, 2017
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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 CONCLUSION, THE INFECTION WAS NOT DEVICE RELATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    HOLD FOR ADMIN KO

    Description of Event or Problem · 1

    THIS DEVICE WAS EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474639 IPERIA 7 DR-T DF4 PROMRI ICD MRM BIOTRONIK SE & CO. KG 392423

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization