BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 340 DR-T

    MDR report key: 2992874 · Received March 1, 2013

    Report

    Report Number
    1028232-2013-00523
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    November 12, 2010
    Report Date
    February 18, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    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 ENDOCARDITIS WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    THE PT WAS DIAGNOSED WITH NON-ST ELEVATION MI (B)(6) 2010. A TEE PREFORMED IN THE HOSPITAL SHOWED EVIDENCE OF EARLY ENDOCARDITIS. THE PT WAS GIVEN ANTIBIOTICS AND DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89358 LUMAX 340 DR-T ICD MRM BIOTRONIK SE & CO. KG 355267

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization