BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 90CM LENGTH

    MDR report key: 21858269 · Received April 17, 2025

    Report

    Report Number
    1627487-2025-01837
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    June 17, 2024
    Report Date
    May 8, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734401715
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS OCTRODE LEAD, MODEL: 3189, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8100351.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES THAT ONE OF PATIENTS LEAD HAS HIGH IMPEDANCE AND THE OTHER LEAD HAS LOW IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT IS UNABLE TO SET IPG TO MRI MODE, PATIENTS LEAD HAS HIGH IMPEDANCE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT IS ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29824 OCTRODE LEAD KIT, 90CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3189 8100351 05414734401715

    Patients

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