BEUDAMED
    FDA Adverse Event Death Summary report: N

    SETROX S 53

    MDR report key: 1894157 · Received November 4, 2010

    Report

    Report Number
    1028232-2010-02471
    Event Type
    Death
    Date Received
    November 4, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: OVERSENSING AND NOISE WITHOUT SURGICAL INTERVENTION. ANALYSIS: 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

    OVERSENSING WAS REPORTED ON THE ATRIAL LEAD DURING A SENSING TEST. THE CLINICIAN AND DOCTOR REPORT THAT THE PATIENT WAS IN SINUS RHYTHM AT TIME OF SENSING TEST AND THE NOISE WAS REPRODUCIBLE DURING PROVOCATIVE TESTING. IMPEDANCE IN THE ATRIUM IS 440 OHMS AND STEADY SINCE IMPLANT. ON (B)(6) 2010- THE DOCTOR DECIDED TO PROGRAM THE DEVICE TO SINGLE CHAMBER AND SO NO SURGICAL INTERVENTION IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350974
    1 SETROX S 53 PACING LEAD NVN BIOTRONIK SE & CO. KG 350974 04035479087951

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other