BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALOS SR

    MDR report key: 4182722 · Received October 17, 2014

    Report

    Report Number
    1028232-2014-003631
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 6, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    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

    THE PACEMAKER WAS RECEIVED FOR ANALYSIS. PRIOR TO THE ANALYSIS OF THE DEVICE, THE QUALITY DOCUMENTS ACCOMPANYING THE MANUFACTURING PROCESS FOR THIS PACEMAKER WERE RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. PARTICULARLY THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE AS SPECIFIED. UPON RECEIPT, THE CLINICAL OBSERVATION WAS CONFIRMED, THE PACEMAKER WAS NOT INTERROGATABLE. THEREFORE, THE DEVICE WAS RESET USING A TECHNICAL PROGRAMMING TOOL. SUBSEQUENTLY AN INTERROGATION WAS PROPERLY FEASIBLE. FURTHERMORE, THE PACEMAKER'S MEMORY CONTENT WAS ANALYZED INDICATING THAT THE PACEMAKER SWITCHED TO THE SAFETY BACKUP MODE ON (B)(6) 2014 MOST LIKELY DUE TO AN INVALID MEMORY CONTENT. BY DESIGN, THE PACEMAKER PERFORMS SELF-CHECKS AND IS EQUIPPED WITH THE ABILITY TO DETECT AN INVALID MEMORY CONTENT. HOWEVER, IN THE CASE OF AN INVALID MEMORY CONTENT THE PACEMAKER SWITCHES AUTOMATICALLY INTO THE SAFETY BACKUP MODE TO ASSURE THE PATIENTS SAFETY. WHILE IN THIS SAFETY PROGRAM, THE PACEMAKER IS CAPABLE TO DELIVER ANTI-BRADYCARDIA THERAPIES. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. IN SUMMARY, THE CLINICAL OBSERVATION RESULTED MOST LIKELY FROM AN INVALID MEMORY CONTENT. THE ROOT CAUSE FOR THE INVALID MEMORY CONTENT WAS NOT DETERMINABLE. HOWEVER, EXTERNAL INFLUENCES SUCH AS STRONG ELECTROMAGNETIC FIELDS COULD BE TAKEN INTO CONSIDERATION. AFTER A MANUAL CORRECTION OF THE INVALID MEMORY CONTENT THE DEVICE WAS OPERATING AS SPECIFIED. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - THIS DEVICE CANNOT BE INTERROGATED. AT ONE POINT SUDDENLY WHILE DOING IN OFFICE FOLLOW-UP THE COMMUNICATION BETWEEN THE PROGRAMMER AND THE DEVICE WAS LOST. THERE WERE NO WARNING MESSAGES, NO INDICATION OF OUTSIDE DISTURBANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660244 TALOS SR PACEMAKER NVZ BIOTRONIK SE & CO. KG 356254

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization