BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 11820660 · Received May 13, 2021

    Report

    Report Number
    3006630150-2021-02099
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    March 11, 2021
    Report Date
    July 5, 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
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2317-50 (SN: (B)(6)). THE RETURNED LEAD WAS ANALYZED AND VISUAL (MICROSCOPE) AND X-RAY INSPECTION REVEALED THAT ALL CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THE BENT/KINKED LOCATION IS 2 CM FROM THE SET SCREW MARK OF THE CLIK X ANCHOR. THERE ARE NO EXPOSED CABLES AT THE CLIK X ANCHOR SITE FRACTURE LOCATION. THE LEAD GOT KINKED AFTER IT EXITS THE CLIK X ANCHOR RESULTING IN THE REPORTED COMPLAINT. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE ALLEGATIONS OF HIGH IMPEDANCE HAVE BEEN CONFIRMED. IT APPEARS THAT THE LEAD WAS EXPOSED TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT CAUSING THE CABLE FRACTURES RIGHT AT THE ANCHOR POINT. THEREFORE, THE CAUSE TRACED TO A COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES CAUSING THE LOSS AND INADEQUATE STIMULATION DESPITE MULTIPLE REPROGRAMMINGS DONE. IT WAS ALSO REPORTED THAT THE PATIENT NOTICED MORE PAIN. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 7072466.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES CAUSING THE LOSS AND INADEQUATE STIMULATION DESPITE MULTIPLE REPROGRAMMING'S DONE. IT WAS ALSO REPORTED THAT THE PATIENT NOTICED MORE PAIN. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715086 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5039031 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention