BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX T 65

    MDR report key: 4210996 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003806
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 25, 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

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 37 MONTHS, OVERSENSING WAS REPORTED VIA HOME MONITORING. A POSSIBLE LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE LEAD WAS NOT RETURNED TO BIOTRONIK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692407 LINOX T 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351353

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization