BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX ST 53

    MDR report key: 1631005 · Received March 8, 2010

    Report

    Report Number
    1028232-2010-00235
    Event Type
    Injury
    Date Received
    March 8, 2010
    Date of Event
    January 26, 2010
    Report Date
    February 15, 2010
    Manufacturer
    BIOTRONIK SE & CO KG
    Product Code
    JXK
    PMA / PMN Number
    P950038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MFG.

    Description of Event or Problem · 1

    PER REP, THIS LEAD WAS MAL-POSITIONED AND ONE DAY POST-IMPLANT, IT WAS REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX ST 53 PACER LEAD JXK BIOTRONIK SE & CO KG 346366

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization