BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 1977678 · Received January 28, 2011

    Report

    Report Number
    9610579-2011-00004
    Event Type
    Injury
    Date Received
    January 28, 2011
    Report Date
    January 28, 2011
    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), 2011: THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT (WITH KNOWN T-WAVE OVERSENSING) HAD AN EMERGENCY PACEMAKER CHECK BECAUSE ITS CARDIAC RATE WAS AT 45 MIN-1. THE PACEMAKER HAD BEEN PROGRAMMED TO DDI 60 MIN-1 WITH THE VENTRICULAR SENSITIVITY PROGRAMMED AT THE MINIMUM (6MV) BUT SOME T-WAVE OVER SENSING WAS STILL OBSERVED. WHEN THE PACEMAKER WAS INTERROGATED, THE ELECTIVE REPLACEMENT INDICATOR WAS RECEIVED AND THE PACEMAKER WAS THEREFORE IN VVI MODE, AT 70 MIN-1 AND VENTRICULAR SENSITIVITY AT 2.2MV; IN THOSE CONDITIONS, CONTINUOUS T-WAVES OVERSENSING WAS OBSERVED. DURING PREVIOUS FOLLOW UPS, THE DISPLAYED RESIDUAL LONGEVITY WAS AT 77 MONTHS IN (B)(6) 2009, 43 MONTHS IN (B)(6) 2010 & 19 MONTHS IN (B)(6) 2010. IN (B)(6) 2011 (I.E. FOUR MONTHS LATER), THE ERI WAS REACHED. THE PACEMAKER INVOLVED IN THIS MDR REPORT WAS EXPLANTED AND RETURNED FOR ANALYSIS. A NEW PACEMAKER WAS IMPLANTED AND THE VENTRICULAR SENSITIVITY WAS PROGRAMMED TO THE MAXIMUM VALUE TO AVOID T-WAVE OVERSENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S040909

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention