BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 6700090 · Received July 11, 2017

    Report

    Report Number
    1000165971-2017-00552
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 19, 2017
    Report Date
    June 19, 2017
    Manufacturer
    SORIN CRM
    Product Code
    NVY
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2017, THE DEVICE WAS INTERROGATED DURING ROUTINE FOLLOW-UP. BATTERY LONGEVITY WAS 48 MONTHS AT BEGINNING OF SESSION (BATTERY IMPEDANCE WAS 3.09 KOHM AND MAGNET RATE WAS 95). NO HIGH OUTPUTS WERE PROGRAMMED. COMPARING TO PREVIOUS FOLLOW-UPS, LONGEVITY WAS INCREASED: 105 MONTHS ON (B)(6) 2015, 32 MONTHS ON (B)(6) 2015 AND 24 MONTHS (BATTERY IMPEDANCE 2, 7 KOHM AND 96 MAGNET RATE) ON (B)(6) 2016. AT THE END OF SESSION LONGEVITY WAS 52 MONTHS. PRELIMINARY ANALYSIS CONFIRMED THE REPORTED EVENT AND BASED ON AVAILABLE DATA SHOWED NORMAL BATTERY DEPLETION (AS OF (B)(6) 2017).

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2017, THE DEVICE WAS INTERROGATED DURING ROUTINE FOLLOW-UP. BATTERY LONGEVITY WAS 48 MONTHS AT BEGINNING OF SESSION (BATTERY IMPEDANCE WAS 3.09 KOHM AND MAGNET RATE WAS 95). NO HIGH OUTPUTS WERE PROGRAMMED. COMPARING TO PREVIOUS FOLLOW-UPS, LONGEVITY WAS INCREASED: 105 MONTHS ON (B)(6) 2015, 32 MONTHS ON (B)(6) 2015 AND 24 MONTHS (BATTERY IMPEDANCE 2, 7 KOHM AND 96 MAGNET RATE) ON (B)(6) 2016. AT THE END OF SESSION LONGEVITY WAS 52 MONTHS. PRELIMINARY ANALYSIS CONFIRMED THE REPORTED EVENT AND BASED ON AVAILABLE DATA SHOWED NORMAL BATTERY DEPLETION (AS OF (B)(6) 2017).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484605 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVY SORIN CRM SYMPHONY DR 2550 S080131

    Patients

    Seq Age Sex Outcome Treatment
    1