BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 740 DR-T PROMRI

    MDR report key: 6604398 · Received June 1, 2017

    Report

    Report Number
    1028232-2017-01785
    Event Type
    Malfunction
    Date Received
    June 1, 2017
    Date of Event
    March 29, 2017
    Report Date
    May 19, 2017
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 7/28/2017 - ADDED THE EXPLANT DATE. RECEIVED A PARTIAL ANALYSIS. THE ICD FIRST UNDERWENT A STATUS INTERROGATION, AND THE DEVICE MEMORY WAS ANALYZED. THE DEVICE STATUS WAS ERI, 17 CHARGE PROCESSES HAD BEEN DOCUMENTED. THE CHARGE DRAWN FROM THE BATTERY WAS CHECKED AND PROVED TO BE NOT IN ACCORDANCE WITH EXPECTATIONS. THE ICDS CAPABILITY TO PROVIDE THERAPY WAS TESTED. THE ANTIBRADYCARDIC OUTPUT SIGNAL WAS NORMAL AND MATCHED THE PROGRAMMED VALUES. A FIBRILLATION SIGNAL WAS SUPPLIED, AND THE DEVICE DETECTED THE FIBRILLATION SIGNAL AS EXPECTED. THE DETECTION WAS FOLLOWED BY A CHARGE PROCESS THAT WAS ABORTED, WHICH WAS, HOWEVER, DUE TO THE ALREADY SEVERELY DEPLETED BATTERY. THE ICD WAS THEN OPENED. THE VISUAL INSPECTION OF THE INNER STRUCTURE DID NOT SHOW ANY IRREGULARITIES. THE BATTERY VOLTAGE WAS MEASURED. A DISCHARGED BATTERY WAS DETECTED. THE ELECTRONIC MODULE WAS THEN CONNECTED TO AN EXTERNAL VOLTAGE SOURCE AND UNDERWENT ANOTHER ELECTRICAL FUNCTION CHECK. THE CURRENT UPTAKE OF THE ELECTRONIC MODULE WAS TESTED AND PROVED TO BE UNREMARKABLE. THE MODULE WAS COMPLETELY CAPABLE TO PROVIDE THERAPY. THERE WERE NO INDICATIONS OF A MALFUNCTION OF THE ELECTRONIC MODULE. THE BATTERY WAS THEN RETURNED TO THE MANUFACTURER FOR A DESTRUCTIVE ANALYSIS. THE ANALYSIS OF THE BATTERY HAS NOT YET BEEN COMPLETED. AFTER CONCLUSION OF THE BATTERY ANALYSIS, THIS REPORT WILL BE UPDATED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE ICD FIRST UNDERWENT A STATUS INTERROGATION, AND THE DEVICE MEMORY WAS ANALYZED. THE DEVICE STATUS WAS ERI, 17 CHARGE PROCESSES HAD BEEN DOCUMENTED. THE CHARGE DRAWN FROM THE BATTERY WAS CHECKED AND PROVED TO BE NOT IN ACCORDANCE WITH EXPECTATIONS. THE ICDS CAPABILITY TO PROVIDE THERAPY WAS TESTED. THE ANTIBRADYCARDIC OUTPUT SIGNAL WAS NORMAL AND MATCHED THE PROGRAMMED VALUES. A FIBRILLATION SIGNAL WAS SUPPLIED, AND THE DEVICE DETECTED THE FIBRILLATION SIGNAL AS EXPECTED. THE DETECTION WAS FOLLOWED BY A CHARGE PROCESS THAT WAS ABORTED, WHICH WAS, HOWEVER, DUE TO THE ALREADY SEVERELY DEPLETED BATTERY.THE ICD WAS THEN OPENED. THE VISUAL INSPECTION OF THE INNER STRUCTURE DID NOT SHOW ANY IRREGULARITIES. THE BATTERY VOLTAGE WAS MEASURED. A DISCHARGED BATTERY WAS DETECTED. THE ELECTRONIC MODULE WAS THEN CONNECTED TO AN EXTERNAL VOLTAGE SOURCE AND UNDERWENT ANOTHER ELECTRICAL FUNCTION CHECK. THE CURRENT UPTAKE OF THE ELECTRONIC MODULE WAS TESTED AND PROVED TO BE UNREMARKABLE. THE MODULE WAS COMPLETELY CAPABLE TO PROVIDE THERAPY. THERE WERE NO INDICATIONS OF A MALFUNCTION OF THE ELECTRONIC MODULE. THE BATTERY WAS THEN RETURNED TO THE MANUFACTURER FOR A DESTRUCTIVE ANALYSIS. FIRST, A MICROCALORIMETRIC MEASUREMENT OF THE BATTERY WAS PERFORMED. IT FOUND AN INCREASED HEAT TONE. IN A NEXT STEP, THE BATTERY WAS OPENED AND EXAMINED. AN INCREASED BATTER-INTERNAL SELF-DISCHARGE WAS DETECTED IN THE PROCESS, WHICH CONTRIBUTED TO A PREMATURE BATTERY DEPLETION. IN SUMMARY, PREMATURE BATTERY DEPLETION WAS CONFIRMED DURING THE ANALYSIS OF THE ICD. THE CLINICAL OBSERVATION RESULTED FROM AN INCREASED SELF-DISCHARGE OF THE BATTERY. THE ELECTRONIC MODULE PROVED TO BE WITHOUT DEFECTS DURING THE ANALYSIS.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT AFTER THE IMPLANTATION PERIOD OF APPROXIMATELY 50 MONTHS A BATTERY DEPLETION, ERI, WAS NOTED DURING A SCHEDULED FOLLOW-UP. DURING THE LAST FOLLOW-UP IN (B)(6) 2016, 80 PERCENT OF BATTERY CAPACITY WAS MEASURED. THE ICD WAS EXPLANTED. AN EXPLANT DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386620 LUMAX 740 DR-T PROMRI ICD MRM BIOTRONIK SE & CO. KG 381461

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization