BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 90CM LENGTH

    MDR report key: 18155516 · Received November 16, 2023

    Report

    Report Number
    1627487-2023-05446
    Event Type
    Injury
    Date Received
    November 16, 2023
    Date of Event
    October 26, 2023
    Report Date
    December 6, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401715
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE OF EVENT IS ESTIMATED. FURTHER INFORMATION REQUESTED, NOT YET RECEIVED. 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: 3189, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8090563.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED A PRODUCT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FROM INEFFECTIVE THERAPY. FURTHER INVESTIGATION REVEALED MIGRATION OF ONE OF THE LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHERE THE PATIENT'S LEAD AND ANCHOR WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD MIGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292466 OCTRODE LEAD KIT, 90CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3189 8090563 05414734401715

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other SCS ANCHOR.| SCS ANCHOR.| SCS IPG.| SCS LEAD.