BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 20423983 · Received October 10, 2024

    Report

    Report Number
    3006630150-2024-06852
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    July 1, 2024
    Report Date
    October 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R. UPN: M365SC11600. MODEL: SC-1160. SERIAL: (B)(6). BATCH: 350158. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 5143637. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. BATCH: 23746880.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO HIGH IMPEDANCES. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD EXTENDED IPG CHARGING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342764 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5142272 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention