BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 4210993 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003808
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 27, 2014
    Report Date
    October 15, 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 RECEIVED DATA WERE CAREFULLY ANALYSED. THE AVAILABLE IEGMS CONFIRMED THE PRESENCE OF ARTEFACTS IN THE RV CHANNEL, WHICH LED TO THE DETECTION OF VF EPISODES. IN THIS AVAILABLE SECTION NO SHOCKS WERE DELIVERED. 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 60 MONTHS, OVERSENSING WITH INAPPROPRIATE THERAPY WAS REPORTED. THE LEAD WAS CAPPED AND NOT RETURNED TO BIOTRONIK. PART FROM THE SHOCKS, NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692406 LINOX SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization