BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART SD 75/18

    MDR report key: 2190088 · Received June 29, 2011

    Report

    Report Number
    1028232-2011-01446
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 21, 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 - AFTER AN IMPLANTATION TIME OF ABOUT 7 MONTHS, THIS LEAD WAS EXPLANTED DUE TO INAPPROPRIATE SHOCK DELIVERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SMART SD 75/18 ICD LEAD LWS BIOTRONIK, SE & CO KG 359068

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization