BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-6

    MDR report key: 21845615 · Received April 15, 2025

    Report

    Report Number
    3006630150-2025-02507
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    January 29, 2025
    Report Date
    July 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6 UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7083903. BLOCK D.2B; ADDITIONAL APPLICABLE PRODUCT CODE: QRB.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 7083903, UDI: (B)(4). BLOCK D.2B; ADDITIONAL APPLICABLE PRODUCT CODE: QRB. RETURNED LEAD SC-2366-50, SN (B)(6) PASSED ALL TESTING AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. RETURNED LEAD SC-2366-50, SN (B)(6) REVEALED THAT THE PROXIMAL END WAS BENT, FRACTURED BETWEEN CONTACT 7 AND 8. X-RAY INSPECTION OF THE LEAD REVEALED THAT CONTACT 1AND 3 OF THE CABLES WERE FRACTURED WITHIN THE PROXIMAL ARRAY. DAMAGE TO THE LEAD IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. THEREFORE, BASED ON ANALYSIS AND FIELD OBSERVATIONS, ENGINEERS CONCLUDED THAT INADEQUATE STIMULATION AS A RESULT OF LEAD MISALIGNMENT WAS LIKELY THE RESULT OF AN UNINTENDED USER ERROR DURING THE IMPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE SPINAL CORD STIMULATION (SCS) AS THE INITIAL LEAD PLACEMENT DID NOT ALIGN WITH THE PAIN AREA. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEADS WERE REPLACED AND CORRECTLY POSITIONED. THERE WERE NO REPORTED PATIENT ISSUES POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE SPINAL CORD STIMULATION (SCS) AS THE INITIAL LEAD PLACEMENT DID NOT ALIGN WITH THE PAIN AREA. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEADS WERE REPLACED AND CORRECTLY POSITIONED. THERE WERE NO REPORTED PATIENT ISSUES POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348879 LINEAR? 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2366-50 7082346 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention