BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 4300969 · Received December 5, 2014

    Report

    Report Number
    1000165971-2014-00682
    Event Type
    Injury
    Date Received
    December 5, 2014
    Date of Event
    November 7, 2014
    Report Date
    November 8, 2014
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, A VENTRICULAR LEAD RE-INTERVENTION WAS SCHEDULED: NO VENTRICULAR CAPTURE AT MAX OUTPUT, LEAD IMPEDANCE GREATER THAN 3000 OHM. ONCE THE LEAD WAS DISCONNECTED FROM THE PACEMAKER, NORMAL VALUES WERE MEASURED THROUGH THE ANALYZER: R WAVES AT 14.6 MV, V LEAD IMPEDANCE AT1132 OHM, V THRESHOLD OF 1.5 V AT 0.5 MS. THE VENTRICULAR LEAD WAS CAPPED AND A NEW PACEMAKER AND LEAD WERE IMPLANTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A VENTRICULAR LEAD RE-INTERVENTION WAS SCHEDULED: NO VENTRICULAR CAPTURE AT MAX OUTPUT, LEAD IMPEDANCE GREATER THAN 3000 OHM. ONCE THE LEAD WAS DISCONNECTED FROM THE PACEMAKER, NORMAL VALUES WERE MEASURED THROUGH THE ANALYZER: R WAVES AT 14.6 MV, V LEAD IMPEDANCE AT 1132 OHM, V THRESHOLD OF 1.5 V AT 0.5 MS. THE VENTRICULAR LEAD WAS CAPPED AND A NEW PACEMAKER AND LEAD WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786968 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM SYMPHONY DR 2550 S090115

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention