BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 540 DR-T

    MDR report key: 2232536 · Received August 19, 2011

    Report

    Report Number
    1028232-2011-01895
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    June 23, 2011
    Report Date
    August 9, 2011
    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

    THIS PT PRESENTED TO THE FOLLOWING PHYSICIAN WITH A WOUND HEMATOMA. AS OF (B)(6) 2011, THE PHYSICIAN CONSIDERED THIS HEMATOMA RESOLVED. THERE IS NO INDICATION OF ANY INVASIVE INTERVENTION AND ALL RECORDS INDICATE THIS DEVICE REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other