BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS TRIAL LEAD

    MDR report key: 2142587 · Received June 22, 2011

    Report

    Report Number
    1627487-2011-01682
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 24, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 RECEIVED HER SCS TRIAL SYSTEM ON (B)(6) 2011, INCLUDING PERCUTANEOUS LEADS PLACED AT C2 FOR ARM PAIN. IT WAS REPORTED THAT AFTER THE TRIAL PROCEDURE, THE PATIENT COMPLAINED OF DIZZINESS AND ANXIETY. SHE WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. ON (B)(6) 2011, THE PATIENT STATED SHE FELT LIGHT HEADED, NAUSEOUS, AND HAD A LOSS OF APPETITE. SHE ALSO REPORTED FEELING PAIN IN LUNGS AND AN OVERSTIMULATION SENSATION. ON (B)(6) 2011, THE PATIENT REPORTED THAT SHE FELT DIZZY AND HAD PASSED OUT THE NIGHT BEFORE. SHE STATED THAT SHE FELT WEAK AND WANTED HER LEADS REMOVED. THE PATIENT PLANNED TO DISCUSS THE ISSUE WITH HER PHYSICIAN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS TRIAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3333066

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R