BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELA

    MDR report key: 318466 · Received March 2, 2001

    Report

    Report Number
    2182863-2001-00007
    Event Type
    Injury
    Date Received
    March 2, 2001
    Date of Event
    September 15, 2000
    Report Date
    March 2, 2001
    Manufacturer
    ELA MEDICAL, S.A.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER 7 MONTHS OF IMPLANTATION, THIS LEAD WAS REMOVED BECAUSE OF DIAPHRAGMATIC STIMULATION AND A LOSS OF VENTRICULAR SENSING.

    Description of Event or Problem · 1

    AFTER 7 MONTHS OF IMPLANTATION, THIS LEAD WAS REMOVED BECAUSE OF DIAPHRAGMATIC STIMULATION AND A LOSS OF VENTRICULAR SENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9068 STELA VENTRICULAR LEAD DTB ELA MEDICAL, S.A. BT45 H990207

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R