BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART SD 60/16

    MDR report key: 3120333 · Received May 20, 2013

    Report

    Report Number
    1028232-2013-01479
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    December 27, 2012
    Report Date
    April 30, 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 EXPLANTED DUE TO HEMATOMA. 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 HEMATOMA WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    PER THE FOLLOWING PHYSICIAN'S OFFICE, THIS SYSTEM WAS EXPLANTED ON (B)(6) 2012 DUE TO A HEMATOMA. THERE ARE NO KNOWN COMPLAINTS ASSOCIATED WITH THE FUNCTIONALITY OF THIS DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222281 LINOX SMART SD 60/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 359065

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization