BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 22548381 · Received July 18, 2025

    Report

    Report Number
    1627487-2025-03586
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 18, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT INFORMATION AND PATIENT¿S WEIGHT. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LAMITRODE LEAD, MODEL: 3286, UDI: (B)(4), SERIAL: BATCH: 4000169. 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

    IT WAS REPORTED THAT PATIENTS LEAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN PATIENTS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT IS ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277843 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3186 3736585 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS ANCHOR (X2)| SCS IPG| SCS LEAD