BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 12338953 · Received August 18, 2021

    Report

    Report Number
    3006630150-2021-04588
    Event Type
    Injury
    Date Received
    August 18, 2021
    Date of Event
    June 30, 2020
    Report Date
    October 20, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2317-70: SN (B)(6). THE RETURNED LEAD WAS ANALYZED AND IT WAS REVEALED THAT VISUAL (MICROSCOPE) AND X-RAY INSPECTION OF THE LEAD REVEALED THAT ALL CABLES WERE COMPLETELY BROKEN AT THE BENT OR KINKED LOCATION OF THE LEAD. THE BENT OR KINKED 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 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 INADEQUATE STIMULATION AND HIGH IMPEDANCES 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 WHEN THE LEAD MIGRATED. THE PROBABLE CAUSE SELECTED IS CAUSE TRACED TO COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE LEAD MIGRATION AND HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE PHYSICIAN ATTEMPTED TO REVISE LEFT LEAD AND REPLACE, BUT DUE TO SCAR TISSUE HE CHOSE TO REMOVE LEFT LEAD AND REPOSITION RIGHT LEAD TO MIDLINE TO COVER ARMS BILATERALLY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(4). BATCH: 5023194.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND HIGH IMPEDANCES DUE LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE PHYSICIAN ATTEMPTED TO REVISE AND REPLACE THE LEFT LEAD, BUT DUE TO SCAR TISSUE, THE PHYSICIAN CHOSE TO REMOVE LEFT LEAD AND REPOSITION RIGHT LEAD TO MIDLINE TO COVER ARMS BILATERALLY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234360 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5023749 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention