BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 19671539 · Received July 3, 2024

    Report

    Report Number
    3006630150-2024-04287
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 10, 2024
    Report Date
    September 24, 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
    JA
    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-LOT (B)(6), BATCH 7083105.

    Additional Manufacturer Narrative · 0

    SC-2317-70, SERIAL (B)(6), VISUAL AND X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT-KINKED LOCATION OF THE LEAD. THE BENT-KINKED LOCATION IS NEAR THE SET SCREW MARK OF THE CLIK X ANCHOR. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. THE LEAD BECAME KINKED AFTER IT EXITED THE CLIK X ANCHOR RESULTING IN THE REPORTED COMPLAINT. SC-2317-70, SERIAL (B)(6), VISUAL AND X-RAY INSPECTION OF THE LEAD REVEALED THAT ONE CABLES WERE COMPLETELY BROKEN AT THE BENT-KINKED LOCATION OF THE LEAD. THE BENT-KINKED LOCATION IS NEAR THE SET SCREW MARK OF THE CLIK X ANCHOR. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. THE LEAD BECAME KINKED AFTER IT EXITED THE CLIK X ANCHOR RESULTING IN THE REPORTED COMPLAINT. ADDITIONALLY, THERE IS A BURN MARK ALONG THE LEAD BODY DUE TO THE USE OF ELECTROCAUTERY. THIS DAMAGE IS A RESULT OF THE TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BOTH OF THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS DISPLAYED HIGH IMPEDANCES. THERE WAS NO STIMULATION ISSUE REPORTED. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE TWO LEAD WERE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BOTH OF THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS DISPLAYED HIGH IMPEDANCES. THERE WAS NO STIMULATION ISSUE REPORTED. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE TWO LEAD WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132723 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7083121 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention