BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 11004530 · Received December 14, 2020

    Report

    Report Number
    3006630150-2020-06192
    Event Type
    Injury
    Date Received
    December 14, 2020
    Date of Event
    September 8, 2020
    Report Date
    February 16, 2021
    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
    AS
    Reporter Occupation
    PHYSICIAN

    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 3137092. PRODUCT FAMILY- SCS-LINEAR LEADS, UPN M365SC2317700, MODEL SC-2317-70, SERIAL (B)(6), LOT 3140804. PRODUCT FAMILY- SCS-LINEAR FIXATION, UPN M365SC43180, MODEL SC-4318, SERIAL NI, LOT 24445152. THE CLIK ANCHOR WAS NOT RETURNED FOR ANALYSIS, THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE RETURNED LEAD SC-2317-70 SN (B)(6) WAS ANALYZED AND THE VISUAL, MICROSCOPE, AND X-RAY INSPECTION REVEALED THAT ALL CABLES WERE COMPLETELY BROKEN AT THE BENT LOCATION OF THE LEAD. THE BENT LOCATION IS 2 CM FROM THE SET SCREW MARK OF THE CLIK X ANCHOR. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. THE LEAD BECAME KINKED AFTER IT EXITS THE CLIK X 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. WILL ALL THE AVAILABLE INFORMATION, ENGINEERS CONCLUDED THAT LEAD MIGRATION WHICH WAS CONFIRMED BY THE PHYSICIAN, IS A KNOWN INHERENT RISK WITH USE OF THE LEADS. THE EVENT OF INADEQUATE STIMULATION AND HIGH IMPEDANCE MEASUREMENTS WERE FOUND TO BE CAUSED BY A LEAD FRACTURE. THE LEAD BECAME BENT AFTER EXITING THE CLIK X ANCHOR WHICH EXPOSED THE BENT LOCATION TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT THAT CAUSED THE LEAD CABLES TO FRACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES ON ALL CONTACTS ON ONE LEAD. IT WAS ALSO NOTED THERE WAS LEAD MIGRATION. REPROGRAMMING WAS ATTEMPTED, HOWEVER, THE ISSUE DID NOT RESOLVE. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEAD WAS REPLACED. POST-OPERATIVELY THE PAIN AREAS WERE COVERED.

    Additional Manufacturer Narrative · 1

    NO CODE AVAILABLE WAS USED AS THERE IS NO EQUIVALENT FDA CODE FOR SURGERY. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2317700; MODEL: SC-2317-70; SERIAL: (B)(4); LOT: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES ON ALL CONTACTS ON ONE LEAD. IT WAS ALSO NOTED THERE WAS LEAD MIGRATION. REPROGRAMMING WAS ATTEMPTED, HOWEVER, THE ISSUE DID NOT RESOLVE. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEAD WAS REPLACED. POST-OPERATIVELY THE PAIN AREAS WERE COVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465910 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 3146118 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention