BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD01 65/16

    MDR report key: 4211012 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003755
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    August 18, 2014
    Report Date
    October 14, 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

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 7 MONTHS, OVERSENSING WITHOUT INAPPROPRIATE THERAPY WAS REPORTED VIA HOME MONITORING. THE PATIENT WAS HOSPITALIZED AND THE LEAD WAS REPLACED ON 17. SEPTEMBER 2014. A SUSPECTED INSULATION DEFECT WAS OBSERVED. THE LEAD WAS LATER RETURNED TO BIOTRONIK. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692411 SD01 65/16 ENDOCARDIAL DEFIBRILLATION LEAD NVY BIOTRONIK SE & CO. KG 365486

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization