BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 640 VR-T DX PROMRI

    MDR report key: 4211008 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003829
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 17, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P050023
    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 EXISTING PRODUCTION DOCUMENTS, AS WELL AS THE RETURNED DEVICE DATA. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS REVIEWED. THE PRODUCTION DOCUMENTS DID NOT SHOW ANY ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS HAD BEEN CARRIED OUT CORRECTLY. THE RETURNED MEMORY EXCERPT WAS ANALYZED AND CONFIRMED THE CLINICAL OBSERVATION. THE ICD DID NOT DOCUMENT ANY IMPEDANCE MEASUREMENT SINCE THE IMPLANTATION OF THE LEFT-VENTRICULAR ASSIST DEVICE (LVAD) BECAUSE OF AN AUTOMATIC RESET. THE ICD RESET WAS PERFORMED AUTOMATICALLY BY THE ICD BECAUSE IT DETECTED AN EXTERNAL HIGH VOLTAGE. BASED ON THE AVAILABLE DATA, THE CAUSE FOR THE CLINICAL OBSERVATION COULD NOT BE DETERMINED. DUE TO THE SIMULTANEOUS OCCURRENCE OF LVAD IMPLANTATION AND AUTOMATIC RESET, IT CAN, HOWEVER, BE ASSUMED THAT INVASIVE EXTERNAL INFLUENCES DURING THE LVAD IMPLANTATION, SUCH AS ELECTROCAUTERING OR EXTERNAL DEFIBRILLATION, LED TO THE OBSERVED DEVICE BEHAVIOR. IT WAS REPORTED THAT A RE-INITIALIZATION OF THE DEVICE WAS CARRIED OUT. FOLLOWING THE REPROGRAMMING, THE DEVICE BEHAVED AS EXPECTED. IN SUMMARY, THE ANALYSIS SHOWED NO INDICATIONS OF A DEVICE DEFECT BASED ON THE AVAILABLE INFORMATION

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 15 MONTHS, IT WAS REPORTED THAT SINCE THE PATIENT HAD AN LVAD (LEFT-VENTRICULAR ASSIST DEVICE) IMPLANTED THE IMPEDANCE MEASUREMENT OF THE ICD HAD NOT BEEN SUCCESSFUL. ALL OTHER MEASUREMENT VALUES WERE UNREMARKABLE. THE ICD IS IMPLANTED ON THE RIGHT SIDE. THE ICD IS CURRENTLY STILL ACTIVELY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692040 LUMAX 640 VR-T DX PROMRI ICD LWS BIOTRONIK SE & CO. KG 381472

    Patients

    Seq Age Sex Outcome Treatment
    1 Other