BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLIA S 53

    MDR report key: 8703470 · Received June 17, 2019

    Report

    Report Number
    1028232-2019-02388
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    April 5, 2019
    Report Date
    May 20, 2019
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    UDI-DI
    04035479118266
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499612 SOLIA S 53 PACING LEAD NVN BIOTRONIK SE & CO. KG 377177 04035479118266

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization