BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 60

    MDR report key: 3232169 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01928
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 4, 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 LEAD UNDER COMPLAINT WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR LEAD AS WELL AS THE DEVICE DATA RETURNED FOR ANALYSIS. THE MANUFACTURING PROCESS FOR THIS LEAD 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. THE RETURNED DEVICE DATA WERE ANALYZED. THE INSPECTION REVEALED A GRADUAL INCREASE OF THE VENTRICULAR PACING IMPEDANCE WITH VALUES UP TO > 3200 OHM AND THRESHOLD VALUES OF 3.2V AT 1.0MS. IN SUMMARY, THE LEAD WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR LEAD MANUFACTURING.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANT DURATION OF NEARLY 6 YEARS A GRADUAL INCREASE OF IMPEDANCE WAS REPORTED. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED. THE LEAD COULD NOT BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330304 SELOX ST 60 PACER LEAD NVN BIOTRONIK SE & CO. KG 346367

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization