BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 1020669 · Received March 27, 2008

    Report

    Report Number
    2182863-2008-00017
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ELA MEDICAL, S.A.S.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS FROM THE MANUFACTURER IS PENDING.

    Description of Event or Problem · 1

    DURING AN INTERVENTION FOR THE VENTRICULAR LEAD (GUIDANT), THE SETSCREW ON THIS PACEMAKER COULD NOT BE RE-ENGAGED; THEY COULD NOT FIND OR TIGHTEN DOWN THE SETSCREW ON THE PACEMAKER. THEREFORE, THE PACEMAKER WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY CARDIAC PACEMAKER DXY ELA MEDICAL, S.A.S. 2550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R