BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX SL 75/16 STEROID

    MDR report key: 3952817 · Received July 23, 2014

    Report

    Report Number
    1028232-2014-002477
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 28, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE AVAILABLE IEGMS CONFIRMED THE PRESENCE OF ARTEFACTS IN THE FF AND RV CHANNELS, WHICH LED TO THE DETECTION OF VF EPISODES AND THE DELIVERED SHOCKS. FURTHERMORE, AT THE END OF THE RECORDINGS THE PACING IMPEDANCE SHOWED A SLIGHT DECREASE. DIAGNOSTIC IMAGES OF THE LEAD WERE NOT RECEIVED FOR ANALYSIS. BASED ON THE AVAILABLE DATA, THE PRESENCE OF AN INSULATION DAMAGE ON THE LEAD CANNOT BE RULED OUT. IN SPITE OF THE INFORMATION AVAILABLE FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION. AN ANALYSIS OF THE LEAD WOULD BE NECESSARY FOR A ROOT CAUSE INVESTIGATION. SHOULD ADDITIONAL INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE FOR ANALYSIS, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 103 MONTHS, OVERSENSING WITH INAPPROPRIATE SHOCKS WAS REPORTED. THE LEAD WAS CAPPED AND LEFT IN THE PATIENT. APART FROM THE SHOCKS, NO FURTHER ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430795 KENTROX SL 75/16 STEROID ICD LEAD NVY BIOTRONIK SE & CO. KG 347353

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization