BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 19459380 · Received June 4, 2024

    Report

    Report Number
    3006630150-2024-03590
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    January 25, 2024
    Report Date
    July 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: 7083248.

    Description of Event or Problem · 0

    IT WEAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DESPITE REPROGRAMMING ATTEMPT. SEVERAL HIGH IMPEDANCES WERE NOTED ON THE LEADS. IT WAS ALSO STATED THAT THE LEAD WAS FRACTURED BUT NOT CONFIRMED BY IMAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DESPITE REPROGRAMMING ATTEMPT. SEVERAL HIGH IMPEDANCES WERE NOTED ON THE LEADS. IT WAS ALSO STATED THAT THE LEAD WAS FRACTURED BUT NOT CONFIRMED BY IMAGING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. THE EXPLANTED LEADS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202684 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7083094 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention