BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 18671050 · Received February 8, 2024

    Report

    Report Number
    1627487-2024-00568
    Event Type
    Injury
    Date Received
    February 8, 2024
    Date of Event
    January 29, 2024
    Report Date
    February 8, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: OCTRODE, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 5241031. 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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEAD HAD A FRACTURE. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192889 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3186 5241031 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS ANCHORX2.| SCS IPG.| SCS LEAD.