BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYMPHONY

    MDR report key: 3132593 · Received May 24, 2013

    Report

    Report Number
    9610579-2013-00039
    Event Type
    Death
    Date Received
    May 24, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 15, 2013
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITES STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, EXTERNAL DEFIBRILLATION SHOCKS WERE APPLIED TO THE PT BECAUSE VENTRICULAR FIBRILLATION (VF) OCCURRED. THE DEFIBRILLATION PADDLE WAS PLACED ON THE RIGHT SIDE, WHICH WAS THE SAME SIDE OF PACEMAKER POCKET. THERE WAS BURN LIKE TRACE AROUND PACEMAKER POCKET AREA; HOWEVER, IT WAS UNK IF THE TRACE WAS DUE TO THE DEFIBRILLATION SHOCKS OR NOT. THE PT DIED BECAUSE THE VF WAS NOT TERMINATED. WHEN THE DEVICE WAS INTERROGATED AFTER THE DEFIBRILLATION SHOCKS, LEAD'S IMPEDANCE WAS UNDER 250 OHM AND BATTERY IMPEDANCE WAS 1.05 KOHM. WHEN THE DEVICE WAS INTERROGATED AGAIN AFTER PT'S DEATH, LEAD IMPEDANCE WAS FLUCTUATING FROM <200 OHM TO >3000 OHM AND BATTERY IMPEDANCE WAS AROUND 3 KOHM. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231428 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S041030

    Patients

    Seq Age Sex Outcome Treatment
    1 Death