BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 21517717 · Received March 4, 2025

    Report

    Report Number
    1627487-2025-01022
    Event Type
    Injury
    Date Received
    March 4, 2025
    Date of Event
    February 10, 2025
    Report Date
    March 4, 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. 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. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: OCTRODE LEAD KIT, 60CM LENGTH, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 5030689.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY, AND THE SYSTEM WAS UNABLE TO ENTER MRI MODE AS THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 TO EXPLANT THE SYSTEM. IT IS UNKNOWN WHICH LEAD CAUSED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472821 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3186 5024977 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other SCS ANCHOR (X2)| SCS LEAD