BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 18456145 · Received January 5, 2024

    Report

    Report Number
    3006630150-2023-08459
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    October 4, 2022
    Report Date
    March 8, 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
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). LOT: 7072504.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). LOT: 7072504. THE ALLEGATION OF HIGH IMPEDANCES HAS BEEN CONFIRMED. THE RETURNED LEAD SC-2317-70 SN (B)(6) WAS ANALYZED AND FOUND MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT LOCATION OF THE LEAD. THE BENT LOCATION IS NEAR THE SET SCREW MARK OF THE CLIK ANCHOR. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. THE LEAD BECAME KINKED AFTER IT EXITED THE CLIK ANCHOR RESULTING IN THE REPORTED COMPLAINT. IT APPEARS THAT THE LEAD WAS EXPOSED TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT CAUSING THE CABLE FRACTURES RIGHT AT THE ANCHOR POINT. THE RETURNED LEAD SC-2317-70 SN (B)(6) WAS ANALYZED AND REVEALED THAT ALL CABLES WERE COMPLETELY BROKEN AT THE BENT LOCATION OF THE LEAD. THE BENT LOCATION IS NEAR THE SET SCREW MARK OF THE CLIK ANCHOR. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. THE LEAD BECAME KINKED AFTER IT EXITED THE CLIK ANCHOR RESULTING IN THE REPORTED COMPLAINT. IT APPEARS THAT THE LEAD WAS EXPOSED TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT CAUSING THE CABLE FRACTURES RIGHT AT THE ANCHOR POINT. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICES WERE USED PER THE INSTRUCTIONS FOR USE (IFU) PRODUCT LABEL. ADDITIONALLY, SYSTEM FAILURE, CAN OCCUR AT ANY TIME DUE TO RANDOM FAILURE(S) OF THE COMPONENTS. THESE EVENTS, WHICH MAY INCLUDE DEVICE FAILURE, LEAD BREAKAGE, HARDWARE MALFUNCTIONS, LOOSE CONNECTIONS, ELECTRICAL SHORTS OR OPEN CIRCUITS AND LEAD INSULATION BREACHES, CAN RESULT IN INEFFECTIVE PAIN CONTROL. UNDESIRABLE STIMULATION MAY OCCUR OVER TIME DUE TO CELLULAR CHANGES IN TISSUE AROUND THE ELECTRODES, CHANGES IN ELECTRODE POSITION, LOOSE ELECTRICAL CONNECTIONS AND/OR LEAD FAILURE, ALL OF WHICH ARE KNOWN RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION LEADS DISPLAYED HIGH IMPEDANCES WHICH RESULTED IN INADEQUATE STIMULATION. REPROGRAMMING AROUND THE IMPEDANCES NO LONGER PROVIDED RELIEF, THEREFORE, THE PATIENT UNDERWENT A PROCEDURE WHERE THE TWO LEADS WERE REPLACED. THERE WERE NO REPORTED ISSUES POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S SPINAL CORD STIMULATION LEADS DISPLAYED HIGH IMPEDANCES WHICH RESULTED IN INADEQUATE STIMULATION. REPROGRAMMING AROUND THE IMPEDANCES NO LONGER PROVIDED RELIEF, THEREFORE, THE PATIENT UNDERWENT A PROCEDURE WHERE THE TWO LEADS WERE REPLACED. THERE WERE NO REPORTED ISSUES POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569051 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7072477 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention