BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION? CX

    MDR report key: 22894142 · Received August 26, 2025

    Report

    Report Number
    3006630150-2025-06858
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    June 13, 2025
    Report Date
    April 30, 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
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2408560. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7081157. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON DEVICE INTERROGATION THE PATIENTS LEFT SPINAL CORD STIMULATION (SCS) LEAD HAD FRACTURED FOLLOWING A NON-DEVICE RELATED INCIDENT. A LOSS OF THERAPY IN THE LEFT SIDE OF HER BACK AND LEFT LEG WAS ALSO NOTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED LEADS WERE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON DEVICE INTERROGATION THE PATIENTS LEFT SPINAL CORD STIMULATION (SCS) LEAD HAD FRACTURED FOLLOWING A NON-DEVICE RELATED INCIDENT. A LOSS OF THERAPY IN THE LEFT SIDE OF HER BACK AND LEFT LEG WAS ALSO NOTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UPON DEVICE INTERROGATION THE PATIENTS LEFT SPINAL CORD STIMULATION (SCS) LEAD HAD FRACTURED FOLLOWING A NON-DEVICE RELATED INCIDENT. A LOSS OF THERAPY IN THE LEFT SIDE OF HER BACK AND LEFT LEG WAS ALSO NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7076665 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention| O