BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 18430065 · Received January 2, 2024

    Report

    Report Number
    1627487-2023-06147
    Event Type
    Injury
    Date Received
    January 2, 2024
    Date of Event
    October 31, 2023
    Report Date
    January 17, 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
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF HIGH IMPEDANCES WAS CONFIRMED. AS RECEIVED, THE OCTRODE LEAD HAD ALL ITS INTERNAL WIRES BROKEN, THAT WOULD CAUSE HIGH IMPEDANCE AND WOULD REFLECT HIGH IMPEDANCES. THE DAMAGE IS CONSISTENT WITH AN OVERSTRESS CONDITION OR SUDDEN EVENT THE LEAD WAS SUBJECTED WHILE IN VIVO. 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 LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7252295.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PATIENT'S LEADS WAS EXHIBITING HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 IN WHICH THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. AT THE TIME OF THE REPLACEMENT, THE LEAD WAS FOUND TO BE BENT. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615315 OCTRODE LEAD KIT, 60CM LENGTH STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW ABBOTT MEDICAL 3186 7252295 05415067017246

    Patients

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