BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION? CX

    MDR report key: 24773918 · Received April 3, 2026

    Report

    Report Number
    3006630150-2026-02040
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    December 1, 2025
    Report Date
    May 15, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE APPROXIMATED, EVENT OCCURRED IN (B)(6) 2025. BLOCK D2B: PRO CODE (PRODUCT CODE): LGW, QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2317-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7072659. MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM. UNIQUE IDENTIFIER (UDI): (B)(4). INVESTIGATION RESULTS: ALL EXPLANTED DEVICES WERE NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THAT ALL DEVICES MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INVESTIGATION CONCLUSION: ALL EXPLANTED DEVICES WERE NOT RETURNED FOR ANALYSIS AND THE COMPLAINT AS REPORTED COULD NOT BE CONFIRMED. RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS UNABLE TO DETERMINE A PROBABLE CAUSE FOR THE COMPLAINT AND THE CONCLUSION CODE CAUSE NOT ESTABLISHED WILL BE USED.

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE APPROXIMATED, EVENT OCCURRED IN DECEMBER 2025. BLOCK D2B: PRO CODE (PRODUCT CODE): LGW, QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2317-50 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7072659 MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM UNIQUE IDENTIFIER (UDI): (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISTAL PART OF ONE OF THE SPINAL CORD STIMULATOR (SCS) LEADS WAS SHEERED AND FRACTURED DURING AN IPG REPLACEMENT PROCEDURE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS WERE REPLACED AND THAT THE PATIENT WAS DOING WELL WITH GOOD COVERAGE POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISTAL PART OF ONE OF THE SPINAL CORD STIMULATOR (SCS) LEADS WAS SHEERED AND FRACTURED DURING AN IPG REPLACEMENT PROCEDURE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS WERE REPLACED AND THAT THE PATIENT WAS DOING WELL WITH GOOD COVERAGE POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29643 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-50 5061777 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1