BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 20297416 · Received September 24, 2024

    Report

    Report Number
    3006630150-2024-06397
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    June 11, 2024
    Report Date
    September 24, 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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: INFINION CX UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7082036.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS' LEFT LEAD SHOWED HIGH IMPEDANCES AND CAUSED THE PATIENT TO EXPERIENCE INADEQUATE STIMULATION FROM THE SPINAL CORD STIMULATOR (SCS) SYSTEM. REPROGRAMMING WAS PERFORMED BUT DID NOT RESOLVE THE INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEADS WERE REPLACED AND IS DOING WELL POST OPERATIVELY. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234103 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7081643 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Required Intervention