BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 2113632 · Received May 24, 2011

    Report

    Report Number
    1028232-2011-01161
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 23, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - THIS LEAD WAS REMOVED DUE TO INAPPROPRIATE SHOCK. THE PT WAS MOVED TO INTENSIVE CARE. NO FURTHER INFO IS AVAILABLE. IF ADDITIONAL INFO IS OBTAINED, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK