BEUDAMED
    FDA Adverse Event Summary report: N

    ITREL

    MDR report key: 264638 · Received February 18, 2000

    Report

    Report Number
    MW4002692
    Date Received
    February 18, 2000
    Date of Event
    January 7, 2000
    Report Date
    January 13, 2000
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    GZB
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WITH ADVANCED PARKINSON'S DISEASE WHO UNDERWENT BILATERAL SUBTHALAMIC STIMULATORS IMPLANTS ON 01/13/2000 AS PART OF FDA IDE#G980035. SURGERY WAS UNCOMPLICATED. ON DAY 4 POSTOPERATIVELY, PT HAD A SUDDEN CARDIORESPIRATORY ARREST AND EXPIRED IN HOSP. POSTMORTUM REVEALED A PULMONARY EMBOLUS AS CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL IMPLANTABLE PULSE GENERATOR GZB MEDTRONIC, INC. 3387-DBS 7424-IPG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR