BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 8826818 · Received July 25, 2019

    Report

    Report Number
    1000165971-2019-00440
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    July 3, 2019
    Report Date
    March 2, 2020
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY ANALYSIS SHOWED THAT THE IMPOSSIBILITY TO INTERROGATE THE DEVICE AND TO PERFORM TESTS WAS CAUSED BY DATA CORRUPTION IN THE DEVICE MEMORY. THE CORRUPTION WAS MOST LIKELY DUE TO A SINGLE EVENT UPSET (SEU) POSSIBLY CAUSED BY THE REPORTED RADIATION THERAPY SESSIONS UNDERWENT BY THE PATIENT. DEVICE RETURN ANALYSIS DID NOT REVEAL ANY DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    REPORTEDLY, THE SUBJECT PACEMAKER WAS INTERROGATED AND IT WAS THEN IMPOSSIBLE TO PERFORM ANY TEST. AFTER THAT, IT WAS IMPOSSIBLE TO INTERROGATE THE SUBJECT PACEMAKER WITH SEVERAL DIFFERENT PROGRAMMERS. THE PATIENT HAD HAD 10 RADIOTHERAPY SESSIONS AT THE LOWER ABDOMEN SINCE (B)(6)2019 (THE LAST SESSION WAS PERFORMED ON (B)(6)2019 ). THE PACEMAKER WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    REPORTEDLY, THE SUBJECT PACEMAKER WAS INTERROGATED AND IT WAS THEN IMPOSSIBLE TO PERFORM ANY TEST. AFTER THAT, IT WAS IMPOSSIBLE TO INTERROGATE THE SUBJECT PACEMAKER WITH SEVERAL DIFFERENT PROGRAMMERS. THE PATIENT HAD 10 RADIOTHERAPY SESSIONS AT THE LOWER ABDOMEN SINCE (B)(6) 2019 (THE LAST SESSION WAS PERFORMED ON (B)(6) 2019). THE PACEMAKER WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, THE SUBJECT PACEMAKER WAS INTERROGATED AND IT WAS THEN IMPOSSIBLE TO PERFORM ANY TEST. AFTER THAT, IT WAS IMPOSSIBLE TO INTERROGATE THE SUBJECT PACEMAKER WITH SEVERAL DIFFERENT PROGRAMMERS. THE PATIENT HAD 10 RADIOTHERAPY SESSIONS AT THE LOWER ABDOMEN SINCE (B)(6) 2019 (THE LAST SESSION WAS PERFORMED ON (B)(6) 2019). THE PACEMAKER WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621217 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM SYMPHONY DR 2550 S060227

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention