BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX TD 65/16

    MDR report key: 3000760 · Received March 12, 2013

    Report

    Report Number
    1028232-2013-00584
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    March 27, 2012
    Report Date
    February 26, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THEREFORE THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE WERE RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST. THE BIOTRONIK STERILIZATION PROTOCOL CONFIRMED THAT ALL STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, ETC., WERE IN THEIR SPECIFIED RANGES. ALSO, THE INVESTIGATION OF THE MICROBIOLOGICAL INDICATORS SHOWED THE SUCCESSFUL COMPLETION OF THE STERILIZATION PROCESS. IN SUMMARY, THE INFECTION WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO VEGETATION. NO OTHER INFORMATION WAS PROVIDED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103129 LINOX TD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 351337

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization