BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 540 DR-T

    MDR report key: 2943809 · Received January 31, 2013

    Report

    Report Number
    1028232-2013-00167
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    November 14, 2012
    Report Date
    January 17, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THERE WAS A POCKET REVISION DONE DUE TO A HEMATOMA. THIS DEVICE REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42089 LUMAX 540 DR-T ICD LEAD MRM BIOTRONIK SE & CO. KG 360346

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization