BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART S 65

    MDR report key: 4210994 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003886
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 20, 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

    NEITHER THE ICD NOR THE LEAD WERE RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE AVAILABLE PRODUCTION DOCUMENTS AND THE RETURNED DEVICE DATA OF THE ICD. THE MANUFACTURING PROCESSES OF THE LEAD AND OF THE ICD WERE REVIEWED. THE PRODUCTION DOCUMENTS DID NOT SHOW ANY ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS HAD BEEN CARRIED OUT CORRECTLY. THE AVAILABLE ICD DATA WERE INSPECTED, AND THIS CONFIRMED THE CLINICAL OBSERVATION. THE IEGMS SHOWED INTERFERENCE IN THE RV AND IN THE FF CHANNEL, WHICH LED TO SEVERAL CHARGE PROCESSES. IN ADDITION, THERE WAS A DROP IN PACING IMPEDANCE IN THE RV CHANNEL SINCE THE LAST FOLLOW-UP ON (B)(6) 2014. BASED ON THE AVAILABLE DATA, THE CAUSE FOR THE CLINICAL OBSERVATION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 41 MONTHS OVERSENSING WITH INAPPROPRIATE SHOCK DELIVERY WAS REPORTED. THERE ARE NO FURTHER DETAILS ABOUT THIS COMPLAINT AVAILABLE TO US AT PRESENT. SHOULD WE RECEIVE ADDITIONAL DATA, WE WILL INFORM YOU ACCORDINGLY. THE LEAD WAS NOT RETURNED TO BIOTRONIK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691607 LINOX SMART S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 369818

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization