BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 19000689 · Received March 28, 2024

    Report

    Report Number
    3006630150-2024-01887
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    January 29, 2024
    Report Date
    April 17, 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
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). LOT: 7082803. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. SERIAL: N/A. LOT: 32307201.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6) LOT: 7082803. PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180 MODEL: SC-4318 SERIAL: N/A LOT: 32307201.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENTS SPINAL CORD STIMULATION LEADS MIGRATED ON SEVERAL OCCASIONS WHICH WAS CONFIRMED THROUGH IMAGING. THERE WERE NO SYMPTOMS DUE TO THE EVENT, HOWEVER, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE ONE LEAD AND ONE CLIK ANCHOR WERE EXPLANTED AND REPLACED. THE OTHER DEVICES REMAIN IMPLANTED. THERE WERE NO REPORTED ISSUES POSTOPERATIVELY. THE DEVICES WERE NOT RETURNED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICES WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENTS SPINAL CORD STIMULATION LEADS MIGRATED ON SEVERAL OCCASIONS WHICH WAS CONFIRMED THROUGH IMAGING. THERE WERE NO SYMPTOMS DUE TO THE EVENT, HOWEVER, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE ONE LEAD AND ONE CLIK ANCHOR WERE EXPLANTED AND REPLACED. THE OTHER DEVICES REMAIN IMPLANTED. THERE WERE NO REPORTED ISSUES POSTOPERATIVELY. THE DEVICES WERE NOT RETURNED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384994 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7083847 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention