BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE TRIAL LEAD, 60 CM

    MDR report key: 2192460 · Received June 21, 2011

    Report

    Report Number
    1627487-2011-00842
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    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

    IT WAS REPORTED THAT DURING THE PROCEDURE TO IMPLANT A TRIAL LEAD, THE PATIENT STOPPED BREATHING. THE PROCEDURE WAS ABORTED. THE PATIENT'S BREATHING REPORTEDLY RESUMED SHORTLY AFTERWARDS, AND HE IS RECOVERING. THE PHYSICIAN BELIEVES THAT THE BREATHING ISSUE WAS RELATED TO MEDICATION USED PRIOR TO THE PROCEDURE AND PLANS TO IMPLANT THE PATIENT AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE TRIAL LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3365307

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention