BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERVENE DEFIB LEAD

    MDR report key: 119482 · Received September 11, 1997

    Report

    Report Number
    1640319-1997-00781
    Event Type
    Death
    Date Received
    September 11, 1997
    Date of Event
    August 11, 1997
    Report Date
    August 15, 1997
    Manufacturer
    SULZER INTERMEDICS INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A NON-PACER RELATED DEATH WAS REPORTED. THE REPORTER INDICATED DIFFICULTY RECEIVING TELEMETRY POST MARTUM WITH LOW LEAD IMPEDANCES AND LOW CELL VOLTAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERVENE DEFIB LEAD Implant PACEMAKER LEAD LWS SULZER INTERMEDICS INC. 497-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death (438-07) (LEAD)| (101-09) (PACEMAKER)| (497-22) (LEAD)