BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALOS DR

    MDR report key: 3962015 · Received July 28, 2014

    Report

    Report Number
    1028232-2014-002622
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 14, 2014
    Report Date
    July 18, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER ITS RECEIPT, THE IMPLANT UNDERWENT A STATUS INTERROGATION AND IT COULD NOT BE INTERROGATED. THEN, THE PACEMAKER'S ABILITY TO PROVIDE THERAPY WAS TESTED. NO ANTIBRADYCARDIC OUTPUT SIGNAL COULD BE MEASURED. THE DEVICE WAS THEREFORE OPENED AND THE ELECTRONIC MODULE ANALYZED. THE BATTERY WAS COMPLETELY DISCHARGED. IN THE FURTHER COURSE OF THE ANALYSIS, THE COMPONENTS OF THE ELECTRONIC MODULE WERE INSPECTED. HOWEVER, NO VISUAL DAMAGE COULD BE OBSERVED. INTENSIVE ELECTRICAL TESTS WERE THEN PERFORMED AT THE ELECTRONIC MODULE. A DAMAGED CIRCUIT WAS IDENTIFIED, WHICH CAUSED ABOVE-AVERAGE HIGH POWER CONSUMPTION AND SUBSEQUENTLY LED TO THE CLINICAL OBSERVATION. IT WAS REPORTED THAT AN EXTERNAL DEFIBRILLATION HAD BEEN PERFORMED. IT IS VERY LIKELY THAT THE DAMAGE TO THE CIRCUIT RESULTED FROM AN ELECTRICAL OVERLOAD OF THE PACEMAKER, WHICH WAS CAUSED BY THE EXTERNAL DEFIBRILLATION. THE IMPLANT IS PRINCIPALLY PROTECTED AGAINST THE ENERGY THAT IS NORMALLY INDUCED BY AN EXTERNAL DEFIBRILLATION. HOWEVER, DAMAGE TO THE DEVICE DUE TO EXTERNAL DEFIBRILLATION CANNOT BE RULED OUT COMPLETELY. THE MANUFACTURING PROCESS OF 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. IN SUMMARY, DAMAGE TO THE ELECTRONIC MODULE WAS DISCOVERED. IT CAN BE ASSUMED THAT THE REPORTED EXTERNAL DEFIBRILLATION WAS THE CAUSE OF THE DAMAGE. THERE WERE NO INDICATIONS OF A MATERIAL DEFECT OR MANUFACTURING ERROR.

    Description of Event or Problem · 1

    OUS MDR - FIVE MONTHS AFTER IMPLANTATION, IT WAS REPORTED THAT A PATIENT WAS DEFIBRILLATED BY AN EMERGENCY ROOM PHYSICIAN DURING RESUSCITATION. FOLLOWING DEFIBRILLATION, THE PACEMAKER COULD NO LONGER BE INTERROGATED AND NO PACING WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437441 TALOS DR PACEMAKER DXY BIOTRONIK SE & CO. KG 356248

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization