BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 6693626 · Received July 7, 2017

    Report

    Report Number
    1627487-2017-03584
    Event Type
    Injury
    Date Received
    July 7, 2017
    Date of Event
    June 16, 2017
    Report Date
    September 15, 2025
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALLEGATION IS AGAINST 1 OF 2 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS OCTRODE LEAD, MODEL: 3186, UDI: (B)(4), BATCH: 3153429.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES THAT SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN CUT LEAD WAS EXPLANTED TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT IS ASSOCIATED WITH THE ISSUE.

    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 HAS TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED DURING THE PATIENT'S IPG REPLACEMENT PROCEDURE (REFERENCE MFR. REPORT: 1627487-2017-03671), THE PHYSICIAN CUT THE LEADS FOR EASE OF REMOVAL OF THE LEAD FROM THE IPG HEADER. REPLACEMENT LEADS WERE IMPLANTED DURING THE PROCEDURE. ADDITIONALLY, THE CUT LEADS WERE ALSO LEFT IMPLANTED. STIMULATION WAS RESTORED FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474647 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3153429

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other MODEL 1192(X2), SCS ANCHOR.| MODEL 3788, SCS IPG.| SCS LEAD.| MODEL 1192(X2), SCS ANCHOR| MODEL 3788, SCS IPG