BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 DR-T

    MDR report key: 2190069 · Received June 29, 2011

    Report

    Report Number
    1028232-2011-01447
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BIOTRONIK, SE AND CO KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - SEVEN DAYS POST-IMPLANT, A SHOCK IMPEDANCE OF > 150 OHMS WAS REPORTED. THE DEVICE WAS EXPLANTED AND THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 DR-T ICD MRM BIOTRONIK, SE AND CO KG 355267

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization