BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KORA

    MDR report key: 7518372 · Received May 16, 2018

    Report

    Report Number
    1000165971-2018-00489
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Date of Event
    April 23, 2018
    Report Date
    July 23, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    REPORTEDLY, THE PACEMAKER WAS FOUND IN STANDBY MODE ON (B)(6) 2018 AND RE-INITIALIZED. THE PATIENT MENTIONED THAT HE HAD BEEN FEELING ILL FOR ABOUT 10 DAYS AND THAT A MAMMOGRAPHY WAS PERFORMED ON (B)(6) 2018. PRELIMINARY ANALYSIS RESULTS CONFIRMED THE REPORTED SWITCH IN STANDBY MODE. IT WAS MOST PROBABLY DUE TO A SINGLE EVENT UPSET (SEU). THE DEVICE WAS PROPERLY RE-INITIALIZED DURING THE FOLLOW-UP PERFORMED ON (B)(6) 2018 AND ITS NORMAL FUNCTIONING WAS RESTORED.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY SORIN THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES.

    Description of Event or Problem · 1

    REPORTEDLY, THE PACEMAKER WAS FOUND IN STANDBY MODE ON (B)(6) 2018 AND RE-INITIALIZED. THE PATIENT MENTIONED THAT HE HAD BEEN FEELING ILL FOR ABOUT 10 DAYS AND THAT A MAMMOGRAPHY WAS PERFORMED ON (B)(6) 2018. PRELIMINARY ANALYSIS RESULTS CONFIRMED THE REPORTED SWITCH IN STANDBY MODE. IT WAS MOST PROBABLY DUE TO A SINGLE EVENT UPSET (SEU). THE DEVICE WAS PROPERLY RE-INITIALIZED DURING THE FOLLOW-UP PERFORMED ON (B)(6) 2018 AND ITS NORMAL FUNCTIONING WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363150 KORA IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP SORIN GROUP ITALIA S.R.L. - CRM FACILITY KORA 100 DR S0018

    Patients

    Seq Age Sex Outcome Treatment
    1