BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 17101693 · Received June 9, 2023

    Report

    Report Number
    1627487-2023-02747
    Event Type
    Injury
    Date Received
    June 9, 2023
    Date of Event
    May 20, 2023
    Report Date
    July 9, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. ADDITIONAL COMPONENT POTENTIALLY INVOLVED IN THE EVENT INCLUDES: COMMON DEVICE NAME: SCS LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6183676.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PATIENT'S LEADS MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 IN WHICH THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453104 OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD LGW ABBOTT MEDICAL 3186 6183676 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SCS IPG (X1)| SCS LEAD (X1)