BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 5986204 · Received September 29, 2016

    Report

    Report Number
    1000165971-2016-00585
    Event Type
    Injury
    Date Received
    September 29, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 6, 2016
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE WAS REPLACED ON (B)(6) 2016. THE REASON STATED WAS DUE TO THE REPORTED EVENT, AN ISSUE WITH THE RATE RESPONSE.

    Description of Event or Problem · 1

    DURING THE FOLLOW-UP OF THE SUBJECT SYMPHONY PACEMAKER, RATE RESPONSE SENSOR (PREVIOUSLY SET WITH MV+G) WAS TURNED OFF AND THE PROGRAMMER WOULD NOT ALLOW THE SENSOR TO BE PROGRAMMED BACK ON AT THE END OF THE FOLLOW-UP. ATTEMPTS TO RE-INITIALIZE THE SENSOR OR TO RE-PROGRAM OTHER PARAMETERS FAILED. THE USER WAS ABLE TO PROGRAM THE G-SENSOR ON AND RATE RESPONSIVE PACING WAS OBSERVED; HOWEVER, HE WAS STILL UNABLE TO PROGRAM MV+G DURING THIS FOLLOW-UP. PLEASE REVIEW THE PROGRAMMER FILES, AND EXPLAIN WHY MV+G ("TWIN TRACE / RR-AUTO") CANNOT BE PROGRAMMED FOR THIS DEVICE AND PROVIDE A PATIENT MANAGEMENT RECOMMENDATION FOR THIS PATIENT.

    Description of Event or Problem · 1

    DURING THE FOLLOW-UP OF THE SUBJECT SYMPHONY PACEMAKER, RATE RESPONSE SENSOR (PREVIOUSLY SET WITH MV+G) WAS TURNED OFF AND THE PROGRAMMER WOULD NOT ALLOW THE SENSOR TO BE PROGRAMMED BACK ON AT THE END OF THE FOLLOW-UP. ATTEMPTS TO RE-INITIALIZE THE SENSOR OR TO RE-PROGRAM OTHER PARAMETERS FAILED. THE USER WAS ABLE TO PROGRAM THE G-SENSOR ON AND RATE RESPONSIVE PACING WAS OBSERVED; HOWEVER, HE WAS STILL UNABLE TO PROGRAM MV+G DURING THIS FOLLOW-UP. PLEASE REVIEW THE ATTACHED PROGRAMMER FILES, AND EXPLAIN WHY MV+G ("TWIN TRACE / RR-AUTO") CANNOT BE PROGRAMMED FOR THIS DEVICE AND PROVIDE A PATIENT MANAGEMENT RECOMMENDATION FOR THIS PATIENT.

    Description of Event or Problem · 1

    DURING THE FOLLOW-UP OF THE SUBJECT SYMPHONY PACEMAKER, RATE RESPONSE SENSOR (PREVIOUSLY SET WITH MV+G) WAS TURNED OFF AND THE PROGRAMMER WOULD NOT ALLOW THE SENSOR TO BE PROGRAMMED BACK ON AT THE END OF THE FOLLOW-UP. ATTEMPTS TO RE-INITIALIZE THE SENSOR OR TO RE-PROGRAM OTHER PARAMETERS FAILED. THE USER WAS ABLE TO PROGRAM THE G-SENSOR ON AND RATE RESPONSIVE PACING WAS OBSERVED; HOWEVER, HE WAS STILL UNABLE TO PROGRAM MV+G DURING THIS FOLLOW-UP. PLEASE EXPLAIN WHY MV+G ("TWIN TRACE / RR-AUTO") CANNOT BE PROGRAMMED FOR THIS DEVICE AND PROVIDE A PATIENT MANAGEMENT RECOMMENDATION FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638850 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM SYMPHONY DR 2550 S050425

    Patients

    Seq Age Sex Outcome Treatment
    1