BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 18725939 · Received February 16, 2024

    Report

    Report Number
    3006630150-2024-00755
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    January 24, 2024
    Report Date
    August 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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: SCS-LINEAR LEADS UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7083017.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS A SUSPECTED LEAD FRACTURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS A SUSPECTED LEAD FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431490 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7082973 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention