BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 21389115 · Received February 14, 2025

    Report

    Report Number
    3006630150-2025-00748
    Event Type
    Injury
    Date Received
    February 14, 2025
    Date of Event
    November 6, 2023
    Report Date
    February 14, 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
    TX, 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: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6) BATCH: 7082930. PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180 MODEL: SC-4318 SERIAL: N/A BATCH: 31893284.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE DUE TO LEAD MIGRATION. THE PATIENT HAD SIGNIFICANTLY WORSENING LOW BACK PAIN AND PAIN IN HER RIGHT LOWER EXTREMITY. THE PATIENT ALSO EXPERIENCED HIGH IMPEDANCES. X-RAYS WERE PERFORMED AND CONFIRMED THE LEAD MIGRATION AND SHOWED THE BOTTOM LEAD APPEARS TO BE WITHDRAWING FROM THE EPIDURAL SPACE. THE EXPLANTED DEVICES WERE RETAINED BY THE FACILITY AND WILL NOT BE RETURNED. THE PATIENT IS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982719 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7082912

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention