BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYLOS VR COATED

    MDR report key: 3193440 · Received June 27, 2013

    Report

    Report Number
    1028232-2013-01780
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 13, 2013
    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

    (B)(4) 2013 - AN IMPLANT DATE WAS PROVIDED TO US AND HAS BEEN ADDED TO THIS REPORT. UPON RECEIPT, THE DEVICE WAS ELECTRICAL ANALYSED. DURING INITIAL INTERROGATION THE PROGRAMMER DISPLAYED A WARNING MESSAGE INDICATING A SOFTWARE CORRUPTION. THEREFORE, THE PACEMAKER'S MEMORY CONTENT WAS ANALYSED REVEALING AN INVALID MEMORY CONTENT. THE DEVICE WAS OPERATING IN THE SAFETY BACKUP MODE AS A RESULT OF THE DETECTION OF INVALID MEMORY CONTENT. BY DESIGN, THE PACEMAKER PERFORMS SELF-CHECKS. IN GENERAL, THE DEVICE IS EQUIPPED WITH THE ABILITY TO DETECT INVALID MEMORY CONTENT. HOWEVER, IN THE CASE OF INVALID MEMORY AREAS, THE DEVICE CANNOT CORRECT THE MEMORY CONTENT AND SWITCHES INTO THE SAFETY BACKUP MODE TO ASSURE THE PATIENTS SAFETY. WHILE IN THIS SAFETY PROGRAM, THE PACEMAKER IS CAPABLE TO DELIVER ANTI-BRADYCARDIA THERAPIES. UPON INTERROGATION A DEVICE STATUS ERROR MESSAGE APPEARS TO NOTIFY THE PHYSICIAN. HOWEVER, THE ACTIVATION OF THE SAFETY BACKUP MODE DOES NOT INDICATE A MATERIAL OR MANUFACTURING PROBLEM. THIS IS SUPPORTED BY THE FACT THAT AFTER A MANUAL CORRECTION OF THE INVALID MEMORY AREAS, THE RAM APPLICATION WAS OPERATING AS EXPECTED. THE PACEMAKER WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. 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. IN SUMMARY, THE ANALYSIS REVEALED AN INVALID MEMORY CONTENT LEADING TO THE CLINICAL OBSERVATION. AFTER A MANUAL CORRECTION, THE DEVICE WAS OPERATING AS EXPECTED. THE ROOT CAUSE FOR THE INVALID MEMORY CONTENT WAS NOT DETERMINABLE. HOWEVER, EXTERNAL INFLUENCES SUCH AS STRONG ELECTROMAGNETIC FIELDS COULD BE TAKEN INTO CONSIDERATION. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT THIS DEVICE COULD NOT BE INTERROGATED AND IT WAS NOT AT ERI. THIS IS ALL OF THE INFORMATION THAT WAS PROVIDED TO US. THE IMPLANT AND EVENT DATES WERE NOT PROVIDED. THERE WAS NO EXPLANT DATE GIVEN. HOWEVER, THIS PACEMAKER HAS BEEN RETURNED FOR ANALYSIS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293984 CYLOS VR COATED PACEMAKER DXY BIOTRONIK SE & CO. KG 349813

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization