BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX SR 45

    MDR report key: 1812157 · Received August 18, 2010

    Report

    Report Number
    1028232-2010-01755
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 26, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING 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 MANUFACTURING.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO HIGH CAPTURE THRESHOLD AFTER A LEFT SHOULDER SURGERY, WHICH IS BELIEVED TO HAVE CONTRIBUTED TO THE LEAD ISSUES. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED. LEADS REMOVED: SELOX SR 53, (B)(4), MDR 1028232-2010-01756.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX SR 45 PACER LEAD NVZ BIOTRONIK SE & CO. KG 343081

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization