BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 3811735 · Received May 15, 2014

    Report

    Report Number
    1000165971-2014-00271
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 18, 2014
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN PREVIOUS FOLLOW-UP MDR, IT SHOULD HAVE BEEN (B)(4) 2014.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE REMAINING LONGEVITY ESTIMATION ON (B)(6) 2014 (28 MONTHS) WAS LOWER THAN EXPECTED ACCORDING TO THE PREVIOUS FOLLOW-UP (ON (B)(6) 2013, 42 MONTHS).

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE REMAINING LONGEVITY ESTIMATION ON (B)(6) 2014 (28 MONTHS) WAS LOWER THAN EXPECTED ACCORDING TO THE PREVIOUS FOLLOW-UP (ON (B)(6) 2013, 42 MONTHS).

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE REMAINING LONGEVITY ESTIMATION ON (B)(6) 2014 (28 MONTHS) WAS LOWER THAN EXPECTED ACCORDING TO THE PREVIOUS FOLLOW-UP (ON (B)(6) 2013, 42 MONTHS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290865 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM SYMPHONY DR 2550

    Patients

    Seq Age Sex Outcome Treatment
    1