BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTICA 7 VR-T DX DF-1 PROMRI

    MDR report key: 8901175 · Received August 16, 2019

    Report

    Report Number
    1028232-2019-03525
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    August 15, 2019
    Report Date
    August 15, 2019
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    UDI-DI
    04035479142209
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN EROSION 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 EROSION WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    THIS DEVICE WAS EXPLANTED DUE TO INFECTION AND EROSION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696327 INTICA 7 VR-T DX DF-1 PROMRI ICD LWS BIOTRONIK SE & CO. KG 404633 04035479142209

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization