BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFECTA S

    MDR report key: 3193464 · Received June 27, 2013

    Report

    Report Number
    1028232-2013-01781
    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

    THE RECEIVED PACEMAKER WAS STILL IN THE STERILE BLISTER. UPON RECEIPT, THE PACEMAKER WAS SUBJECTED TO AN ELECTRICAL INCOMING INSPECTION. DURING INITIAL INTERROGATION THE DEVICE WAS OPERATING IN A SAFETY BACKUP MODE AND THE PROGRAMMER PROMOTED A RE-INITIALISATION REQUEST. THE PACEMAKER¿S MEMORY CONTENT WAS INSPECTED. THE INSPECTION REVEALED, THAT THE DEVICE SWITCHED INTO THE SAFETY BACKUP MODE AS A RESULT OF A SEVERELY INVALID MEMORY CONTENT. AFTER THE MANUAL CORRECTION OF THE INVALID MEMORY CONTENT, THE DEVICE WAS OPERATING AS EXPECTED. BY DESIGN, THE PACEMAKER PERFORMS SELF-CHECKS. IN GENERAL, THE DEVICE IS EQUIPPED WITH THE ABILITY TO DETECT AND REPAIR INVALID MEMORY CONTENT. HOWEVER, IN THE CASE OF MULTIPLE 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 USER. 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 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.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT THIS DEVICE COULD NOT BE INTERROGATED. THERE WERE NOT DATES PROVIDED. HOWEVER, THE DEVICE HAS BEEN RETURNED FOR ANALYSIS, SO IT WAS EXPLANTED. THIS IS ALL THE INFORMATION AVAILABLE TO USE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294033 EFFECTA S PACEMAKER DXY BIOTRONIK SE & CO. KG 375431

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization