BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 60

    MDR report key: 3173913 · Received June 17, 2013

    Report

    Report Number
    1028232-2013-01706
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 4, 2013
    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 WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL AND AN ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION SHOWED CUTTINGS IN THE INSULATION, WHICH OCCURRED MOST LIKELY DURING SURGERY. COAGULATED BLOOD WAS FOUND IN THE LUMEN OF THE LEAD. DURING FURTHER ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE LEAD PROVED TO BE WITHIN SPECIFICATIONS AND FLAWLESS THROUGHOUT ITS INSPECTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS SYSTEM DEMONSTRATED LOSS OF CAPTURE AND INTERMITTENT OUTPUT AT THE POST IMPLANT CHECK. THE NEXT DAY THE PHYSICIAN REPOSITIONED THE LEAD AND RECONNECTED IT TO THE DEVICE. THE SYSTEM STILL HAD INTERMITTENT OUTPUT WHEN THE LEAD WAS COILED UNDER THE DEVICE. AFTER SEVERAL ATTEMPTS TO CLEAN THE LEAD TIP AND THE HEADER AND REPOSITION THE LEAD IN THE HEADER, THE PHYSICIAN REQUESTED A NEW DEVICE. THE NEW PACEMAKER, HAD THE SAME ISSUE, SO THE PHYSICIAN REPLACED THIS LEAD WITH, WHICH FUNCTIONED WITHOUT ISSUE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274449 SELOX ST 60 PACER LEAD NVN BIOTRONIK SE & CO. KG 346367

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization