BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44 LEAD KIT, 60CM LENGTH

    MDR report key: 22021592 · Received May 14, 2025

    Report

    Report Number
    1627487-2025-02134
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    April 29, 2025
    Report Date
    June 27, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734402071
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. FURTHER INFORMATION WAS REQUESTED BUT NOT 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: PENTA 3MM LEAD, 60 CM, MODEL: 3228, UDI: (B)(4), BATCH: 3150031.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION AT THE PADDLE SITE WHEN TURNING THE DEVICE ON. SURGICAL INTERVENTION MAY TAKE PLACE IN THE FUTURE TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CAUSED/CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750091 LAMITRODE 44 LEAD KIT, 60CM LENGTH SCS LEAD LGW ABBOTT MEDICAL 3244 3104022 05414734402071

    Patients

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