BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILESTO 7 HF-T DF4

    MDR report key: 5137638 · Received October 8, 2015

    Report

    Report Number
    1028232-2015-03727
    Event Type
    Injury
    Date Received
    October 8, 2015
    Date of Event
    September 28, 2015
    Report Date
    September 28, 2015
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE RETURNED DEVICE DATA, AS WELL AS THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE RETURNED DEVICE DATA WAS INSPECTED. THE INSPECTION REVEALED THAT THE ICD ACTIVATED THE BACKUP MODE, BECAUSE IT DETECTED INVALID MEMORY CONTENT DURING AN AUTOMATIC SIGNATURE CHECK, WHICH IS INITIATED EVERY 24 HOURS. THE INVALID MEMORY CONTENT WAS DETECTED DURING THE SIGNATURE CHECK ON (B)(6) 2015 AT 01:03 AM. IN GENERAL, THE ICD IS EQUIPPED WITH THE ABILITY TO DETECT AND REPAIR INVALID MEMORY CONTENT. IN CASE THAT THE INVALID MEMORY CONTENT CANNOT BE CORRECTED, THE ICD WILL, BY DESIGN, ACTIVATE THE BACKUP MODE TO ASSURE THE PATIENTS SAFETY. AN EVALUATION OF DEVICE DATA AFTER RE-INITIALIZATION SHOWED NO INDICATION OF A DEVICE MALFUNCTION. THEREFORE, IT CANNOT BE EXCLUDED THAT THE PRESENCE OF INVASIVE EXTERNAL INFLUENCES, SUCH AS STRONG ELECTROMAGNETIC FIELDS MAY HAVE CONTRIBUTED TO THE CLINICAL OBSERVATION. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN CONCLUSION, THE CLINICAL OBSERVATION RESULTED FROM INVALID MEMORY CONTENT. THE INVALID MEMORY CONTENT WAS AUTOMATICALLY DETECTED BY THE DEVICE LEADING TO THE ACTIVATION OF THE BACKUP MODE. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES IS NOT AFFECTED BY THE SAFETY MECHANISM. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPRESENTATIVE REPORTS THAT THE PATIENT WENT INTO A BACK-UP MODE WITH NO KNOWN CAUSE. THE PATIENT STARTED TO FEEL SYMPTOMATIC AFTER GOING THRU AIRPORT SECURITY. THE DEVICE WAS SUCCESSFULLY RESET. DEVICE FOLLOW-UPS ARE INCLUDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667342 ILESTO 7 HF-T DF4 CRT-D NIK BIOTRONIK SE & CO. KG 383549

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other