BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 2922002 · Received January 4, 2013

    Report

    Report Number
    1627487-2013-02026
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A PROCEDURE FOR AN SCS TRIAL SYSTEM. IT WAS REPORTED, THE PATIENT HAD JUST BEEN BROUGHT INTO SURGERY WHEN SHE PASSED OUT AND STOPPED BREATHING. IT WAS REPORTED, THE PATIENT WAS RESUSCITATED AFTER SEVERAL MINUTES. THE CASE ALLEGEDLY WAS ABORTED AT THE POINT WHERE THE EPIDURAL NEEDLE WAS INSERTED. IT WAS REPORTED, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL 2 HOURS LATER. THE PHYSICIAN STATED, HE BELIEVED THE PATIENT HAD AN ADVERSE REACTION TO THE 220 MICROGRAMS OF FENTANYL THAT WAS ADMINISTERED. THE PHYSICIAN PLANS TO RE-TRIAL THE PATIENT IN A COUPLE OF WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5469 UNK SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R