BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 8577278 · Received May 3, 2019

    Report

    Report Number
    1000165971-2019-00268
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    March 12, 2019
    Report Date
    August 1, 2019
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY ANALYSIS RESULTS CONFIRMED THE REPORTED EVENT. IT WAS MOST PROBABLY DUE TO A SINGLE EVENT UPSET (SEU).

    Description of Event or Problem · 0

    REPORTEDLY, DURING A FOLLOW-UP ON 12 MARCH 2019, THE MAGNET RATE ON THE PROGRAMMER SCREEN AND THE PRINTOUT DISPLAYED 31 MIN-1. HOWEVER, THE BATTERY IMPEDANCE WAS 2.36 KOHM AND THE RECOMMENDED REPLACEMENT TIME (RRT) WAS 52 MONTHS. DURING THE FOLLOW-UP, THE PACEMAKER WAS OBSERVED PACING AT THE BASIC RATE ON AN EXTERNAL ECG. THE PACEMAKER WAS EXPLANTED.

    Description of Event or Problem · 0

    REPORTEDLY, DURING A FOLLOW-UP ON (B)(6) 2019, THE MAGNET RATE ON THE PROGRAMMER SCREEN AND THE PRINTOUT DISPLAYED 31 MIN-1. HOWEVER, THE BATTERY IMPEDANCE WAS 2.36 KOHM AND THE RECOMMENDED REPLACEMENT TIME (RRT) WAS 52 MONTHS. DURING THE FOLLOW-UP, THE PACEMAKER WAS OBSERVED PACING AT THE BASIC RATE ON AN EXTERNAL ECG. THE PACEMAKER WAS EXPLANTED.

    Description of Event or Problem · 0

    REPORTEDLY, DURING A FOLLOW-UP ON (B)(6) 2019, THE MAGNET RATE ON THE PROGRAMMER SCREEN AND THE PRINTOUT DISPLAYED 31 MIN-1. HOWEVER, THE BATTERY IMPEDANCE WAS 2.36 KOHM AND THE RECOMMENDED REPLACEMENT TIME (RRT) WAS 52 MONTHS. DURING THE FOLLOW-UP, THE PACEMAKER WAS OBSERVED PACING AT THE BASIC RATE ON AN EXTERNAL ECG. THE PACEMAKER WAS EXPLANTED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A FOLLOW-UP ON (B)(6) 2019, THE MAGNET RATE ON THE PROGRAMMER SCREEN AND THE PRINTOUT DISPLAYED 31 MIN-1. HOWEVER, THE BATTERY IMPEDANCE WAS 2.36 KOHM AND THE RECOMMENDED REPLACEMENT TIME (RRT) WAS 52 MONTHS. DURING THE FOLLOW-UP, THE PACEMAKER WAS OBSERVED PACING AT THE BASIC RATE ON AN EXTERNAL ECG. THE PACEMAKER WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370009 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM SYMPHONY DR 2550 S080415

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention