BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 22777160 · Received August 11, 2025

    Report

    Report Number
    3006630150-2025-06368
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    August 1, 2024
    Report Date
    May 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    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

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN AUGUST 2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7081056, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS PERFORMED ON THE RETURNED LEAD SC-2317-70 SERIAL NUMBER (B)(6) REVEALED THAT THIS LEAD WAS BENT/KINKED NEAR THE SET SCREW MARK OF THE CLIK ANCHOR AND MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE FRACTURE LOCATION. LABORATORY ANALYSIS DETERMINED THAT THE LEAD BECAME BENT/KINKED AT THE EXIT POINT OF THE CLIK ANCHOR, EXPOSING THE BENT LOCATION TO EXCESSIVE MECHANICAL FORCE THAT CAUSED THE CABLES TO FRACTURE AT THE ANCHOR POINT. LEAD SC-2317-70 SERIAL NUMBER (B)(6) HAS BEEN RETURNED TO BOSTON SCIENTIFIC HOWEVER, THE PATIENT CONSENT FOR PRODUCT ANALYSIS WAS NOT RECEIVED; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE DEVICE WILL BE PERFORMED. BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN AUGUST 2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7081056. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT HAD A NON-DEVICE RELATED FALL ONTO THEIR BACK AFTER WHICH THE PATIENT EXPERIENCED A DECREASE IN THEIR SCS THERAPY IMPACT OVER TIME. HIGH IMPEDANCE READINGS WERE DISCOVERED ON SEVERAL CONTACTS OF THE LEADS WHICH WERE LOCATED IN THE LUMBAR AREA. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT HAD A NON-DEVICE RELATED FALL ONTO THEIR BACK AFTER WHICH THE PATIENT EXPERIENCED A DECREASE IN THEIR SCS THERAPY IMPACT OVER TIME. HIGH IMPEDANCE READINGS WERE DISCOVERED ON SEVERAL CONTACTS OF THE LEADS WHICH WERE LOCATED IN THE LUMBAR AREA. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278832 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7081040 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention