BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERVENE

    MDR report key: 86271 · Received April 21, 1997

    Report

    Report Number
    1640319-1997-00348
    Event Type
    Malfunction
    Date Received
    April 21, 1997
    Date of Event
    March 22, 1997
    Report Date
    April 21, 1997
    Manufacturer
    SULZER INTERMEDICS INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE LEAD WAS PACKAGED WITHOUT ADDITIONAL/BACKUP STYLETS. THERE WAS ONLY ONE IN THE PACKAGE. THERE WAS NOT A PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERVENE Implant PACEMAKER LEAD DTB SULZER INTERMEDICS INC. 497-19 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA