BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8-CHANNEL ADAPTER, MDT, 10CM

    MDR report key: 23949731 · Received January 2, 2026

    Report

    Report Number
    1627487-2026-00020
    Event Type
    Injury
    Date Received
    January 2, 2026
    Date of Event
    November 27, 2025
    Report Date
    March 25, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067016119
    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 DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 2 ADAPTERS, 10CM LENGTH; HOWEVER, IT IS UNKNOWN WHICH ADAPTER, 10CM LENGTH, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: ADAPTER, 10CM LENGTH, MODEL: 2311ANS, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6162602.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH ADAPTER IS AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11192 8-CHANNEL ADAPTER, MDT, 10CM SCS ADAPTER LGW ABBOTT MEDICAL 2311 6162602 05415067016119

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other SCS ADAPTER.| SCS IPG.