BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINIX SMART SD 65/18

    MDR report key: 2891025 · Received November 15, 2012

    Report

    Report Number
    1028232-2012-02843
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BIOTRONIK SE & CO KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PACE-SENSE PORTION OF THIS LEAD WAS CAPPED DUE TO NOISE ON (B)(6) 2012. THE PACE-SENSE PORTION OF THIS LEAD WAS REPLACED AND THE SHOCK PORTION OF THIS LEAD REMAINS ACTIVELY IMPLANTED. SHOULD ADD'L INFO BECOME AVAILABLE, THIS FILE WILL BE UPDATED. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINIX SMART SD 65/18 ICD LEAD LWS BIOTRONIK SE & CO KG 359067

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization