BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3950540 · Received July 10, 2014

    Report

    Report Number
    1627487-2014-08108
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 PT HAD TWO MODEL 3086 LEADS FROM THE SAME LOT. IT WAS REPORTED THE PT WAS EXPERIENCING PAIN IN HIS RIGHT FOOT AND SHIN AFTER HIS SCS TRIAL PROCEDURE WHICH BECAME WORSE WITH PROGRAMMING. IT WAS ALSO REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE LEADS WHICH CAUSED THE PT TO REPORTEDLY EXPERIENCE DISCOMFORT IN HIS LEGS. THE PHYSICIAN DECIDED TO REMOVE THE PT'S LEADS. ADD'L FOLLOW UP IDENTIFIED THE PT'S PHYSICIAN ATTEMPTED INJECTIONS IN HIS BACK TO HELP WITH THE PAIN BUT THIS DID NOT RESOLVE THE ISSUE. AN MRI REVEALED PINCHED NERVES IN THE PT'S BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403958 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 4448059

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other