BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 740 HF-T

    MDR report key: 6092285 · Received November 10, 2016

    Report

    Report Number
    1028232-2016-04333
    Event Type
    Death
    Date Received
    November 10, 2016
    Date of Event
    October 28, 2016
    Report Date
    October 28, 2016
    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 WAS IN THE ER DUE TO MULTIPLE SHOCKS DELIVERED. THIS DEVICE COULD NOT BE INTERROGATED. ATTEMPTS TO ELIMINATE ANY POTENTIAL EMI WERE DONE. HOME MONITORING SHOWS 10 SHOCK CHARGES THAT WERE ABORTED AS ATP BROKE MMV. THE LAST MEASURED BATTERY VOLTAGE WAS 3.12 ON (B)(6) 2016. THE DEVICE HAD BEHAVED NORMALLY PRIOR TO ER VISIT. THERE IS NO HISTORY OF EXTERNAL SHOCKS. ALL OTHER TROUBLE SHOOTING TECHNIQUES HAD NEGATIVE RESULTS TO COMMUNICATE WITH DEVICE. ADVISED DEVICE SHOULD BE EXPLANTED AND RETURNED FOR ANALYSIS. ON 11/7/2016 - WE WERE INFORMED THE PATIENT HAD A DNR AND HAS PASSED AWAY. IT IS UNKNOWN IF THE DEVICE WAS EXPLANTED OR WHAT THE CAUSE OF DEATH WAS. DATE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744273 LUMAX 740 HF-T CRT-D NIK BIOTRONIK SE & CO. KG 365608

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death