BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 1523528 · Received November 4, 2009

    Report

    Report Number
    1028232-2009-01363
    Event Type
    Injury
    Date Received
    November 4, 2009
    Report Date
    October 20, 2009
    Manufacturer
    BIOTRONIK SE 7 CO. KG
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    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

    PT CALLED HOME MONITORING TO INFORM THEM THAT THEIR SYSTEM WAS REMOVED FOR INFECTION SHORTLY AFTER THEIR IMPLANT. THE PT COULD NOT REMEMBER THE EXACT DATE OF EXPLANT. IN 2009, THE PT RECEIVED A MEDTRONIC SYSTEM AND THEY DID NOT KNOW WHEN THE SYSTEM WAS EXPLANTED. THE FOLLOWING PHYSICIAN'S OFFICE DID NOT KNOW THE EXACT DATE OF EXPLANT. PHILOS II DR-T, MDR 1028232-2009-01361, SETROX S 53, MDR 1028232-2009-013262.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 45 PACER LEAD DTB BIOTRONIK SE 7 CO. KG 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization