BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 90CM LENGTH

    MDR report key: 19686616 · Received July 7, 2024

    Report

    Report Number
    1627487-2024-09704
    Event Type
    Injury
    Date Received
    July 7, 2024
    Date of Event
    June 25, 2024
    Report Date
    September 2, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401715
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT IS ESTIMATED. 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: 8090562.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATED THAT SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THIS ISSUE. THERAPY WAS RESTORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY AFTER BEING IN AN ACCIDENT. LEAD DIAGNOSTICS SHOWED THAT FIVE CONTACTS ON THE RIGHT LEAD HAD HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167457 OCTRODE LEAD KIT, 90CM LENGTH SCS PERCUTANEOUS LEAD LGW ABBOTT MEDICAL 3189 8090562 05414734401715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SCS ANCHOR (2)| SCS IPG (1)