BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 20815470 · Received December 1, 2024

    Report

    Report Number
    3006630150-2024-08282
    Event Type
    Injury
    Date Received
    December 1, 2024
    Date of Event
    July 9, 2024
    Report Date
    December 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT. BRAND NAME: INFINION CX. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 5180131.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS DISPLAYED HIGH IMPEDANCES. THE PATIENT DID NOT EXPERIENCE ANY STIMULATION ISSUES DUE TO THE IMPEDANCES. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE SCS LEADS WERE REPLACED. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY. THE PATIENT IS RECOVERING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2438269 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 5164324 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention