BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART PROMRI S DX 65/15

    MDR report key: 4250677 · Received November 14, 2014

    Report

    Report Number
    1028232-2014-004090
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    July 28, 2014
    Report Date
    November 5, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. CONCLUSIONS REGARDING THE CLINICAL OBSERVATION CANNOT BE DRAWN FOR THE TIME BEING. THE ANALYSIS WILL CONTINUE AS SOON AS NEW INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    OUS MDR - THE PATIENT WAS ASYMPTOMATIC. SENSING DECLINE OF THE RV-ELECTRODE WAS NOTED. AFTER SEVERAL WEEKS OF NO IMPROVEMENT IN THE RV-SENSING, THE DECISION WAS MADE FOR A REVISION OF THE RV LEAD. THE INTERVENTION WAS DONE ON (B)(6) 2014, AND AS A RESULT RV LEAD SHOWED REGULAR SENSING. NO ARRHYTHMIA OCCURRED DURING THAT TIME BETWEEN THE EVENT AND THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737926 LINOX SMART PROMRI S DX 65/15 ICD LEAD NVY BIOTRONIK SE & CO. KG 377211

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization