BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX S 65

    MDR report key: 2860111 · Received November 29, 2012

    Report

    Report Number
    1028232-2012-02992
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 13, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS CAPPED DUE TO "POOR LEAD POSITION AND CHRONICALLY LOW R WAVES". THE PHYSICIAN ATTEMPTED TO REPOSITION THIS LEAD, HOWEVER THE HELIX WOULD NOT RETRACT, SO THE PHYSICIAN IMPLANTED A NEW LEAD INSTEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX S 65 ICD LEAD LWS BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization