BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 1847124 · Received September 24, 2010

    Report

    Report Number
    9610579-2010-00588
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 31, 2010
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2010: THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, THE PHYSICIAN OBSERVED THAT THE DEVICE SHOWED VARYING LEAD IMPEDANCES DURING FOLLOW-UPS ((B)(4) 2009: > 3000 OHMS; 1 OCT 2009: < 200 OHMS; 6 MAY 2010: 780 OHMS; (B)(4)2010: 780 OHMS). HE DECIDED TO REPLACE THE DEVICE BECAUSE OF THESE VARIATIONS. THE RELATED LEAD REMAINS IMPLANTED AFTER ELECTRICAL MEASUREMENTS WERE PERFORMED WITH THE PSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 M070222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention