BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX JT 53

    MDR report key: 3173910 · Received June 17, 2013

    Report

    Report Number
    1028232-2013-01664
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    April 12, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEADS UNDER COMPLAINT WAS SCRUTINISED, INCLUDING A VISUAL AND AN ELECTRICAL INSPECTION. THE VISUAL INSPECTION OF THE SELOX ST 60 AND OF THE SELOX JT 53 DEMONSTRATED THAT IN BOTH CASES, THE LEAD¿S DISTAL PART WAS PARTLY PULLED OUT OF THE RING ELECTRODE. THEREFORE, THE ADHESIVE RESIDUALS ON THE JOINING SURFACE OF LEAD TIP AND THE LEAD BODY WERE ANALYSED REVEALING NO ANOMALIES. AS THE ROOT CAUSE OF THE OBSERVED DAMAGES, TRACTION FORCES DURING THE SURGERY SHOULD BE TAKEN INTO CONSIDERATION. FURTHER ANALYSIS REVEALED CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE LEADS, MOST LIKELY AS A RESULT OF THE EXPLANTATION PROCEDURE. IN THE COURSE OF THE ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN PARTICULAR, DURING THE ELECTRICAL ANALYSIS OF THE THREE LEADS, THE MEASURED VALUES WERE WITHIN THE TECHNICAL SPECIFICATIONS.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 44 MONTHS, LOSS OF CAPTURE EPISODES WERE NOTED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272935 SELOX JT 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 346368

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization