BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 15462284 · Received September 22, 2022

    Report

    Report Number
    3006630150-2022-04916
    Event Type
    Injury
    Date Received
    September 22, 2022
    Date of Event
    June 8, 2022
    Report Date
    November 8, 2022
    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
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(4). BATCH: 7070165.

    Additional Manufacturer Narrative · 0

    SC-2317-50 SN:(B)(6). THE RETURNED LEAD WAS ANALYZED WHEREIN VISUAL (MICROSCOPE), AND X-RAY INSPECTION REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT AND KINKED LOCATION OF THE LEAD. THE BENT AND KINKED LOCATION WAS 2 CM FROM THE SET SCREW MARK OF THE CLIK X ANCHOR. THERE WERE NO EXPOSED CABLES AT THE FRACTURE LOCATION. THE LEAD GOT KINKED AFTER IT EXITS THE CLIK X ANCHOR RESULTING IN THE REPORTED COMPLAINT. ADDITIONALLY, THE LEAD TAILS WERE CLEANLY CUT, AND THE PROXIMAL ENDS WERE NOT RETURNED. THE CLEAN-CUT DAMAGE WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND NOT CONSIDERED A FAILURE. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE ALLEGATIONS OF HIGH IMPEDANCES AND INADEQUATE STIMULATION HAVE BEEN CONFIRMED. THE FRACTURED CABLES RESULTED IN THE REPORTED HIGH IMPEDANCES AND INADEQUATE STIMULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DESPITE REPROGRAMMING ATTEMPT. IT WAS NOTED THAT CONTACTS ON THE LEAD WERE OUT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DESPITE REPROGRAMMING ATTEMPT. IT WAS NOTED THAT CONTACTS ON THE LEAD WERE OUT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534589 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 7070151 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention