BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 23796853 · Received December 12, 2025

    Report

    Report Number
    3006630150-2025-11438
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    November 18, 2025
    Report Date
    January 9, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B ADDITIONAL APPLICABLE PRODUCT CODE: QRB.

    Additional Manufacturer Narrative · 0

    D2B ADDITIONAL APPLICABLE PRODUCT CODE: QRB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REVISED FOR AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS NOT RECEIVING FULL COVERAGE. THE PHYSICIAN REMOVED THE RIGHT SIDED LEAD AND PLACED A NEW LEAD ON THE LEFT TO GAIN FULL COVERAGE OF THE PATIENTS PAIN. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS DISPOSED OF BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REVISED FOR AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2702974 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-50 7080027 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention