BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 17376401 · Received July 24, 2023

    Report

    Report Number
    3006630150-2023-04293
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    May 1, 2021
    Report Date
    August 17, 2023
    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

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED AT THE BEGINNING OF (B)(6) 2021. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 5140515.

    Additional Manufacturer Narrative · 0

    SC-2317-70 (SN (B)(6)). THE RETURNED LEADS WERE ANALYZED, AND MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION UPON VISUAL AND X-RAY INSPECTION. THERE WERE NO EXPOSED CABLES AT THE FRACTURE LOCATION. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE LEADS WERE EXPOSED TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT WHEN THE PATIENT FELL, CAUSING THE CABLE FRACTURES RIGHT AT THE ANCHOR POINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NO LONGER FEELING ANY STIMULATION DESPITE REPROGRAMMING ATTEMPTS. IT WAS NOTED THAT THE LEADS HAD HIGH IMPEDANCES AND FLUOROSCOPY CONFIRMED MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NO LONGER FEELING ANY STIMULATION DESPITE REPROGRAMMING ATTEMPTS. IT WAS NOTED THAT THE LEADS HAD HIGH IMPEDANCES AND FLUOROSCOPY CONFIRMED MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756542 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5140562 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention