BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/18

    MDR report key: 3843202 · Received June 2, 2014

    Report

    Report Number
    1028232-2014-01852
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 2, 2014
    Report Date
    August 24, 2023
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 IMPEDANCE TREND CONFIRMED THE DECREASE AND INCREASE OF THE SHOCK IMPEDANCE. IN SPITE OF THE INFORMATION AVAILABLE FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION. ALSO SOME ARTEFACTS WERE SEEN IN THE FF CHANNEL. 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

    THIS LEAD HAS HAD ISSUES SINCE 2012. FIRST THE SHOCK IMPEDANCE WAS LOW AND THEN IT WAS HIGH LATER ON. THIS PATIENT SHOWED UP TO THE ER AND THE ICD WAS UNABLE TO BE INTERROGATED. THE PATIENT WAS RESCUED EXTERNALLY BECAUSE HE WAS HAVING VF ARREST. WHEN THE POCKED WAS OPENED THIS LEAD WAS VISUALLY ERODED AND WIRES WERE EXTERNALIZED. THIS LEAD WAS CAPPED AND REPLACED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321287 LINOX SD 65/18 ICD LEAD NVY BIOTRONIK SE & CO. KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Hospitalization