BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMOS DR-R

    MDR report key: 2750642 · Received October 27, 2006

    Report

    Report Number
    1028232-2006-00282
    Event Type
    Injury
    Date Received
    October 27, 2006
    Date of Event
    October 6, 2006
    Report Date
    October 20, 2006
    Manufacturer
    BIOTRONIK, GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SYSTEM EXPLANTED DUE TO INFECTION. OTHER DEVICES IN THIS SYSTEM ARE: LINOX SD 65/16, SN: (B)(4), MDR # 1028232-06-0225. SETROX S 45, SN: (B)(4), MDR# 1028232-06-0224.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMOS DR-R ICD LWS BIOTRONIK, GMBH AND CO. 353220

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization