BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 HF-T

    MDR report key: 2190112 · Received June 30, 2011

    Report

    Report Number
    1028232-2011-01441
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE FOLLOW-UP, A COMPETITIVE REP CALLED TO REPORT THAT THIS DEVICE COULD NOT BE INTERROGATED. INTERROGATION TROUBLESHOOTING WAS PERFORMED, BUT DID NOT RESULT IN THE DEVICE BEING INTERROGATED. A CHEST X-RAY WAS RECOMMENDED TO ASSESS DEVICE DISPOSITION. THIS DEVICE REMAINS IMPLANTED. THIS EVENT HAS NOT BEEN VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 HF-T ICD MRM BIOTRONIK SE & CO. KG 355263

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other