BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 23061904 · Received September 16, 2025

    Report

    Report Number
    3006630150-2025-07633
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    July 21, 2025
    Report Date
    October 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: LGW, QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6) BATCH: 7080804 UDI: (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI UPN: M365SC12320 MODEL: SC-1232 SERIAL: (B)(6) BATCH: 557574 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) LEADS OF THE PATIENT HAD IMPEDANCES. THE PATIENT UNDERWENT A SCS REPLACEMENT PROCEDURE AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ELECTIVELY REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) LEADS OF THE PATIENT HAD IMPEDANCES. THE PATIENT UNDERWENT A SCS REPLACEMENT PROCEDURE AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270467 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7080723

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention