BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 65/18

    MDR report key: 2251011 · Received September 12, 2011

    Report

    Report Number
    1028232-2011-02098
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 30, 2011
    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

    THIS LEAD WAS EXPLANTED AND REPLACED AS THE PHYSICIAN FOUND THE LEAD TO BE "MALPOSITIONED". THE LEAD HAS BEN RETAINED BY THE HOSPITAL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/18 ICD LEAD LWS BIOTRONIK SE & CO. KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization