BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 18716571 · Received February 15, 2024

    Report

    Report Number
    3006630150-2024-00718
    Event Type
    Injury
    Date Received
    February 15, 2024
    Date of Event
    January 25, 2024
    Report Date
    February 15, 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
    KS, 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: 5041502.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCING LOSS OF BILATERAL COVERAGE DUE TO HAVING HIGH IMPEDANCES ON ONE LEAD. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REMOVED, AND TWO NEW LEADS WERE ADDED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102483 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 21022526 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention