BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHORUS

    MDR report key: 87240 · Received April 29, 1997

    Report

    Report Number
    2182863-1997-00002
    Event Type
    Other
    Date Received
    April 29, 1997
    Date of Event
    March 21, 1997
    Report Date
    April 29, 1997
    Manufacturer
    ELA MEDICAL, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON MARCH 21, 1997 PHYSICIAN EXPLANTED DEVICE BECAUSE HE FELT IT WAS NOT SENSING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHORUS Implant CARDIAC PACEMAKER DXY ELA MEDICAL, INC. 6034 G951206

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention