BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION, DUAL 4 CHANNEL 10CM

    MDR report key: 23660177 · Received November 26, 2025

    Report

    Report Number
    1627487-2025-05878
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 21, 2025
    Report Date
    February 27, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734402279
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION. THE ALLEGATION IS AGAINST ONE OF THREE EXTENSIONS; HOWEVER, IT IS UNKNOWN WHICH EXTENSION, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: EXTENSION, MODEL: 3341, UDI: (B)(4), BATCH: 5689655 COMMON DEVICE NAME: EXTENSION, MODEL: 3341, UDI: (B)(4), BATCH: 6854121 D4 CORRECTION: LOT NUMBER SHOULD BE 5864426 RATHER THAN 6854121. D4 CORRECTION: EXPIRATION DATE SHOULD BE 22FEB2019 RATHER THAN 18FEB2021. D6A CORRECTION: IMPLANT DATE SHOULD BE (B)(6) 2017, RATHER THAN (B)(6) 2019. 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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS ESTIMATED. THE ALLEGATION IS AGAINST ONE OF THREE EXTENSIONS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: EXTENSION, MODEL: 3341, UDI: (B)(4), BATCH: 5864426, 5689655.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES THE PATIENT EXPERIENCED INEFFECTIVE THERAPY AND ONE OF THE EXTENSIONS EXHIBITED HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025, WHEREIN THE EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE. IT IS UNKNOWN WHICH EXTENSION ATTRIBUTED TO THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN EXTENSION REPLACEMENT FOR AN UNKNOWN REASON. THE INVESTIGATION DID NOT DETERMINE WHICH EXTENSION ATTRIBUTED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2569172 EXTENSION, DUAL 4 CHANNEL 10CM SCS EXTENSION LGW ABBOTT MEDICAL 3341 5864426 05414734402279

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other SCS ANCHOR (X2)| SCS EXTENSION (X2)| SCS IPG| SCS LEAD (X3)