BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 3940043 · Received July 17, 2014

    Report

    Report Number
    1000165971-2014-00413
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 2, 2014
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS CONFIRMED THAT THE DEVICE WAS MOST PROBABLY DAMAGED DURING SURGERY (INPUT DIODES DAMAGED).

    Description of Event or Problem · 1

    REPORTEDLY, A CARDIAC SURGERY WAS PERFORMED TO A PATIENT IMPLANTED WITH THE SUBJECT PACEMAKER. BEFORE THE SURGERY, AN EKG SHOWED VENTRICULAR PACING AT 60MIN-1. AFTER THE SURGERY, THE DEVICE COULD NOT BE INTERROGATED AND NO PACING PULSES WERE OBSERVED EVEN WITH THE APPLICATION OF A MAGNET. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS. ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT ELECTROCAUTERY WAS USED DURING THE PROCEDURE BUT IT WAS NO POSSIBLE TO CONFIRM IF ANY OTHER ELECTRICAL DEVICE WAS USED.

    Description of Event or Problem · 1

    REPORTEDLY, A CARDIAC SURGERY WAS PERFORMED TO A PATIENT IMPLANTED WITH THE SUBJECT PACEMAKER. BEFORE THE SURGERY, AN EKG SHOWED VENTRICULAR PACING AT 60MIN-1. AFTER THE SURGERY, THE DEVICE COULD NOT BE INTERROGATED AND NO PACING PULSES WERE OBSERVED EVEN WITH THE APPLICATION OF A MAGNET. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS. ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT ELECTROCAUTERY WAS USED DURING THE PROCEDURE BUT IT WAS NO POSSIBLE TO CONFIRM IF ANY OTHER ELECTRICAL DEVICE WAS USED.

    Description of Event or Problem · 1

    REPORTEDLY, A CARDIAC SURGERY WAS PERFORMED TO A PATIENT IMPLANTED WITH THE SUBJECT PACEMAKER. BEFORE THE SURGERY, AN EKG SHOWED VENTRICULAR PACING AT 60MIN-1. AFTER THE SURGERY, THE DEVICE COULD NOT BE INTERROGATED AND NO PACING PULSES WERE OBSERVED EVEN WITH THE APPLICATION OF A MAGNET. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS. ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT ELECTROCAUTERY WAS USED DURING THE PROCEDURE BUT IT WAS NO POSSIBLE TO CONFIRM IF ANY OTHER ELECTRICAL DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417995 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM RHAPSODY SR 2210 S050217

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention