BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 640 VR-T DX PROMRI

    MDR report key: 3193438 · Received June 27, 2013

    Report

    Report Number
    1028232-2013-01793
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR ICD. THE MANUFACTURING PROCESS FOR THIS ICD WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. THERE WAS NEITHER FOR THE LEAD NOR THE ICD ANY INDICATION FOR A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - THE PATIENT COLLAPSED ON (B)(6) 2013 AT HOME, BUT THE DEVICE DID NOT GIVE ANY THERAPY. THE PATIENT WAS RESUSCITATED, AND TRANSPORTED TO THE HOSPITAL. THE LEAD HAD DISLODGED TO THE ATRIUM. IT WAS EXPLANTED AND REPLACED. THIS DEVICE REMAINS ACTIVELY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291974 LUMAX 640 VR-T DX PROMRI ICD LWS BIOTRONIK SE & CO. KG 381472

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization