BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3012262 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-15342
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH TWO PERCUTANEOUS LEADS FROM THE SAME LOT. IT WAS REPORTED THE PATIENT'S VISION IN HER LEFT EYE WAS BLURRED. THE PATIENT'S PHYSICIAN INSTRUCTED HER TO GO TO THE EMERGENCY ROOM. THE EMERGENCY ROOM DID NOT FIND ANYTHING WRONG WITH THE PATIENT'S EYE, HOWEVER SHE WAS ADMITTED TO THE HOSPITAL OVERNIGHT FOR MONITORING. FOLLOW-UP INDICATED THE PATIENT'S SCS SYSTEM IS PERFORMING AS INTENDED AND THE BLURRED VISION IN HER LEFT EYE HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104253 OCTRODE NONE LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3787675

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R SCS IPG: MODEL 3788| IMPLANT DATE: