BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 12048764 · Received June 23, 2021

    Report

    Report Number
    3006630150-2021-03150
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    March 2, 2020
    Report Date
    August 3, 2021
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE LOSS OF STIMULATION AND HIGH IMPEDANCES WERE CAUSED BY LEAD FRACTURES IDENTIFIED DURING LABORATORY ANALYSIS WHERE THE LEAD BODY EXITED THE CLIK X ANCHOR. THE RETURNED LEADS (SERIAL NUMBERS (B)(6) AND (B)(6)) WERE ANALYZED AND BOTH WERE FOUND TO HAVE MULTIPLE CABLES BROKEN AT THE BENT/KINKED LOCATION. THE BENT/KINKED LOCATION IS 2CM FROM THE SET SCREW MARK OF THE CLIK X ANCHOR. EXPOSED CABLES WERE ALSO FOUND AT THE CLIK X ANCHOR SITE. THE LEADS WERE KINKED AFTER EXITING THE CLIK X ANCHOR WHICH RESULTED IN THE LEAD FRACTURES. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT WAS CONFIRMED. LABORATORY ANALYSIS CONFIRMED THAT THE CAUSE OF THE REPORTED COMPLAINT WERE DUE TO LEAD FRACTURES WHICH WERE CAUSED BY COMPONENT FAILURE WHERE THE LEADS EXITED THE CLIK X ANCHORS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT'S LEADS WERE DISPLAYING HIGH IMPEDANCES ON SEVERAL CONTACTS AND THE PATIENT WAS UNABLE TO FEEL STIMULATION. REPROGRAMMING OF THE DEVICE WAS CONDUCTED MULTIPLE TIMES TO PROVIDE STIMULATION AROUND THE HIGH IMPEDANCE CONTACTS WITH MINIMAL SUCCESS. THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE THE LEADS WITH HIGH IMPEDANCES WERE EXPLANTED AND REPLACED WITH NEW ONES. THE PATIENT WAS REPORTED TO BE STABLE POST OPERATIVELY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 5153742.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S LEADS WERE DISPLAYING HIGH IMPEDANCES ON SEVERAL CONTACTS AND THE PATIENT WAS UNABLE TO FEEL STIMULATION. REPROGRAMMING OF THE DEVICE WAS CONDUCTED MULTIPLE TIMES TO PROVIDE STIMULATION AROUND THE HIGH IMPEDANCE CONTACTS WITH MINIMAL SUCCESS. THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE THE LEADS WITH HIGH IMPEDANCES WERE EXPLANTED AND REPLACED WITH NEW ONES. THE PATIENT WAS REPORTED TO BE STABLE POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946319 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5153743 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention