BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 540 HF-T

    MDR report key: 1964057 · Received January 11, 2011

    Report

    Report Number
    1028232-2011-00011
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 4, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED YOUR EVENT DESCRIPTION FOR THE ABOVE MENTIONED DEVICE AND WOULD LIKE TO THANK YOU FOR SUPPORTING OUR POST-MARKET SURVEILLANCE. AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGHOUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES. SHOULD ADDITIONAL RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    THIS PATIENT DEVELOPED A HEMATOMA POST DEVICE IMPLANT. THE PATIENT WAS MONITORED ON AN OUTPATIENT BASIS, BUT AS SWELLING PERSISTED AND EARLY THINNING OF THE SKIN WAS OBSERVED, THE DECISION WAS MADE TO REVISE THE POCKET. THE POCKET REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 AND THE PATIENT WAS DISCHARGED HOME THAT SAME DAY. ALL RECORDS INDICATE THAT THIS DEVICE REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 540 HF-T CRT-D NIK BIOTRONIK SE & CO. KG 360347

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization