BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 20701560 · Received November 16, 2024

    Report

    Report Number
    3006630150-2024-07912
    Event Type
    Malfunction
    Date Received
    November 16, 2024
    Date of Event
    October 7, 2024
    Report Date
    January 8, 2025
    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
    ID, 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: 7080634.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO SPINAL CORD STIMULATION (SCS) LEADS HAS HIGH IMPEDANCES. INTERROGATION REVEALED THAT ONE LEAD IS ENTIRELY BROKEN. THE PATIENT WILL UNDERGO A LEAD REVISION PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO SPINAL CORD STIMULATION (SCS) LEADS HAS HIGH IMPEDANCES. INTERROGATION REVEALED THAT ONE LEAD IS ENTIRELY BROKEN. THE PATIENT WILL UNDERGO A LEAD REVISION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE KEPT BY THE FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144130 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7081002 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention| O