BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S-8 LEAD KIT, 60CM LENGTH

    MDR report key: 22896725 · Received August 26, 2025

    Report

    Report Number
    1627487-2025-04228
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    August 8, 2025
    Report Date
    August 27, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734402231
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D6B - EXPLANT DATE POPULATED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. 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 COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: LAMITRODE S-8 LEAD KIT, 60CM LENGTH, MODEL: 3286, UDI: (B)(4), SERIAL: (B)(6), BATCH: 5172281.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING RECENT WEIGHT LOSS, THE PATIENT EXPERIENCED PAIN AT THE IPG SITE AND INEFFECTIVE THERAPY. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 TO REPLACE THE IPG AND LEADS. IT IS UNKNOWN WHICH LEAD CAUSED THE INEFFECTIVE THERAPY. THERAPY WAS RESTORED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2608740 LAMITRODE S-8 LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3286 5037080 05414734402231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SCS LEAD.