BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2599003 · Received May 30, 2012

    Report

    Report Number
    1627487-2012-09720
    Event Type
    Injury
    Date Received
    May 30, 2012
    Date of Event
    May 4, 2012
    Report Date
    May 4, 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 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

    DURING A PERMANENT SCS SYSTEM IMPLANT PROCEDURE, THE SURGEON ASSESSED THE EPIDURAL SPACE WITH LOSS OF RESISTANCE AND THOUGHT HE WAS SUB-Q. HE PUSHED THE EPIDURAL NEEDLE FROM THE LEAD KIT AND GOT BACK QUITE A BIT OF CEREBROSPINAL FLUID. THE PHYSICIAN CONTINUED WITH THE ATTEMPT TO PLACE THE LEAD BUT WAS UNABLE TO DUE TO PT ANATOMY. THE PHYSICIAN PERFORMED A BLOOD PATCH. THE PT DID NOT REPORT ANY HEADACHES OR SYMPTOMS. THE PT REMAINED ASYMPTOMATIC AND WAS LATER DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3610038

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R