BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 10684027 · Received October 15, 2020

    Report

    Report Number
    3006630150-2020-04887
    Event Type
    Injury
    Date Received
    October 15, 2020
    Date of Event
    September 24, 2020
    Report Date
    December 3, 2020
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED (SC-2317-70: SN (B)(6)) WAS ANALYZED, VISUAL (MICROSCOPE) AND X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE 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 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 ALLEGATION OF HIGH IMPEDANCE HAS BEEN CONFIRMED. IT APPEARS THAT THE LEAD WAS EXPOSED TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT CAUSING THE CABLE FRACTURES RIGHT AT THE ANCHOR POINT. THE PROBABLE CAUSE SELECTED IS CAUSE TRACED TO COMPONENT FAILURE. THE RETURNED (SC-2317-70: SN (B)(6)) WAS ANALYZED, VISUAL (MICROSCOPE) AND X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE 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 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 ALLEGATION OF HIGH IMPEDANCE HAS BEEN CONFIRMED. IT APPEARS THAT THE LEAD WAS EXPOSED TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT CAUSING THE CABLE FRACTURES RIGHT AT THE ANCHOR POINT. THE PROBABLE CAUSE SELECTED IS CAUSE TRACED TO COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS EXPERIENCING LOST STIMULATION DUE TO LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WILL BE RETURNED.

    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: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 5162068.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS EXPERIENCING LOST STIMULATION DUE TO LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147659 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7070610 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention