BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? PRO

    MDR report key: 24489651 · Received March 2, 2026

    Report

    Report Number
    3006630150-2026-01207
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    August 21, 2025
    Report Date
    April 7, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    00191506018733
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D.2B; ADDITIONAL APPLICABLE PRODUCT CODE: QRB ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: INFINION? PRO UPN: M365SC2318700 MODEL: SC-2318-70 SERIAL:(B)(6) BATCH: 5005464 UDI: (B)(4). BRAND NAME: CLIK? X UPN: M365SC43180 MODEL: SC-4318 SERIAL: N/I BATCH: N/I UDI: N/I AT THIS TIME, THE RETURNED LEAD SC-2318-70 SN: (B)(6), LEAD SC-2318-70 SN: (B)(6) AND CLIK ANCHOR SC-4318 ARE CURRENTLY UNDERGOING TECHNICAL ANALYSIS. THE INVESTIGATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: INFINION? PRO, UPN: M365SC2318700, MODEL: SC-2318-70, SERIAL: (B)(6), BATCH: 5005464. UDI: (B)(4). BRAND NAME: CLIK? X, UPN: M365SC43180, MODEL: SC-4318.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED PERSISTENT PAIN SINCE THE SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE. THE FEELING WAS DESCRIBED AS STIMULATION LOCALIZED AROUND THE ANCHOR SITE. MULTIPLE PROGRAMMING STRATEGIES WERE ATTEMPTED, INCLUDING VARIOUS STIMULATION CONFIGURATIONS, BUT THE PAIN RESOLVED ONLY WHEN STIMULATION WAS TURNED OFF. DUE TO THE ONGOING SYMPTOMS, THE CLINICAL TEAM ELECTED TO INSPECT THE LEAD. DURING SURGERY, THE LEAD WAS FOUND TO BE VISIBLY IMPINGED AT THE ANCHOR SITE; THEREFORE, THE LEAD AND CLIK ANCHOR WERE REPLACED. NO ABNORMAL IMPEDANCES WERE MEASURED INTRAOPERATIVELY. THE PATIENT WAS HOSPITALIZED FOR THE PROCEDURE AND WAS SUBSEQUENTLY DISCHARGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED PERSISTENT PAIN SINCE THE SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE. THE FEELING WAS DESCRIBED AS STIMULATION LOCALIZED AROUND THE ANCHOR SITE. MULTIPLE PROGRAMMING STRATEGIES WERE ATTEMPTED, INCLUDING VARIOUS STIMULATION CONFIGURATIONS, BUT THE PAIN RESOLVED ONLY WHEN STIMULATION WAS TURNED OFF. DUE TO THE ONGOING SYMPTOMS, THE CLINICAL TEAM ELECTED TO INSPECT THE LEAD. DURING SURGERY, THE LEAD WAS FOUND TO BE VISIBLY IMPINGED AT THE ANCHOR SITE; THEREFORE, THE LEAD AND CLIK ANCHOR WERE REPLACED. NO ABNORMAL IMPEDANCES WERE MEASURED INTRAOPERATIVELY. THE PATIENT WAS HOSPITALIZED FOR THE PROCEDURE AND WAS SUBSEQUENTLY DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551750 INFINION? PRO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2318-70 5005516 00191506018733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention