BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 60/16

    MDR report key: 1479097 · Received September 15, 2009

    Report

    Report Number
    1028232-2009-01144
    Event Type
    Injury
    Date Received
    September 15, 2009
    Date of Event
    July 17, 2009
    Report Date
    August 18, 2009
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED DUE TO INFECTION. 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 DEVICE WAS RETURNED BY MEDTRONIC, INC WITH A NOTE. PER NOTE, THIS LEAD WAS REMOVED DUE TO INFECTION. THIS PT DID NOT HAVE ANY OTHER BIOTRONIK DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 60/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 363303

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization