BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 21775215 · Received April 4, 2025

    Report

    Report Number
    3006630150-2025-02161
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 9, 2025
    Report Date
    April 23, 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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2317700; MODEL: SC-2317-70; SERIAL: (B)(6); BATCH: 7082890. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK H6. D2B ADDITIONAL PRO CODE: 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: (B)(6). UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR LEADS HAD HIGH IMPEDANCES, AND THE PATIENT WAS EXPERIENCING LOSS OF PAIN RELIEF. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR LEADS HAD HIGH IMPEDANCES, AND THE PATIENT WAS EXPERIENCING LOSS OF PAIN RELIEF. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476511 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-50 7080188 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention