BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 60

    MDR report key: 3232151 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01927
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    April 19, 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 DATA WERE ANALYZED. THE INSPECTION REVEALED A GRADUAL INCREASE OF THE PACING IMPEDANCE WITH VALUES UP TO > 3000 OHM AND THRESHOLD VALUES OF 4.2 V, CONFIRMING THE CLINICAL OBSERVATION. IN SUMMARY, THE LEAD WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION AVAILABLE FOR ANALYSIS, NO CONCLUSION 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 ABOUT 4.5 YEARS A GRADUAL INCREASE OF THE IMPEDANCE (>3000 OHMS) WAS REPORTED. THE LEAD WAS NOT RETURNED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330781 SELOX ST 60 PACER LEAD NVN BIOTRONIK SE & CO. KG 346367

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization