BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 19935053 · Received August 7, 2024

    Report

    Report Number
    3006630150-2024-05183
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    June 18, 2024
    Report Date
    September 19, 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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2317-50 (SN (B)(6)). THE RETURNED LEADS WERE ANALYZED AND VISUAL (MICROSCOPE) AND X-RAY INSPECTION REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEADS, WHICH WAS 2CM FROM THE SET SCREW MARK OF THE CLIK X ANCHOR. THERE WERE NO EXPOSED CABLES AT THE FRACTURE LOCATION. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED ALLEGATION OF LEAD DAMAGE WAS CONFIRMED AND THE CAUSE OF THE BROKEN CABLES WAS DUE TO MECHANICAL STRESS FROM POSSIBLE FLEXING OF THE LEAD AT THE EXIT POINT OF THE CLIK X ANCHOR.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7080861.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD INADEQUATE PAIN RELIEF. FLUOROSCOPY WAS DONE AND CONFIRMED THAT THE LEAD MIGRATED AND HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD INADEQUATE PAIN RELIEF. FLUOROSCOPY WAS DONE AND CONFIRMED THAT THE LEAD MIGRATED AND HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2398659 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 7080535 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention