BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 45

    MDR report key: 4211022 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003900
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. THE VISUAL INSPECTION DEMONSTRATED DEFORMATIONS OF THE INNER COIL CLOSE TO THE IS-1 CONNECTOR PIN. THE SUBSEQUENT ANALYSIS INDICATED THAT THESE DEFORMATIONS WERE CAUSED BY OVER ROTATION OF THE INNER COIL DURING THE EXTENSION OR RETRACTION OF THE FIXATION HELIX. THESE DEFORMATIONS LED TO A CONDUCTOR FRACTURE BETWEEN THE LEAD TIP AND THE IS-1 CONNECTOR PIN. FURTHER, DURING VISUAL INSPECTION THE OUTER COIL WAS FOUND STRETCHED. CUTTINGS IN THE INSULATION WERE FOUND, WHICH OCCURRED MOST LIKELY DURING SURGERY. IN SUMMARY, THE INNER COIL OF THIS LEAD WAS FOUND TO BE FRACTURED , WHICH WAS CAUSED MOST LIKELY DURING THE SURGERY PROCEDURE WHILE OPERATING THE FIXATION MECHANISM. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT. THE PHYSICIAN WAS GOING TO REPOSITION THIS LEAD BUT THERE WAS A BLOCKAGE IN THE CONNECTOR PIN WHICH PREVENTED STYLET ACCESS. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692459 SETROX S 45 PACER LEAD NVN BIOTRONIK SE & CO. KG 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization