BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART T 65

    MDR report key: 6157886 · Received December 9, 2016

    Report

    Report Number
    1028232-2016-04898
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 1, 2016
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    THIS LEAD WAS CAPPED AND REPLACED DUE TO INTERMITTENT OVERSENSING. THERE WERE NO ADVERSE PATIENT SIDE EFFECTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810633 LINOX SMART T 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 369820

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization