BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 10744246 · Received October 27, 2020

    Report

    Report Number
    3006630150-2020-05195
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    March 3, 2020
    Report Date
    November 23, 2020
    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

    MODEL SC-2317-50, SERIAL (B)(6). THE LEAD WAS RETURNED AND THE ALLEGATION OF HIGH IMPEDANCE HAS BEEN CONFIRMED. VISUAL MICROSCOPE AND X-RAY INSPECTION OF THE LEAD 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 FRACTURE LOCATION. THE LEAD GOT KINKED AFTER IT EXITS THE CLIK X ANCHOR RESULTING IN THE REPORTED COMPLAINT. 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 IS CAUSE TRACED TO COMPONENT FAILURE. MODEL SC-2317-50, SERIAL (B)(6). THE LEAD WAS RETURNED AND THE ALLEGATION OF HIGH IMPEDANCE HAS BEEN CONFIRMED. VISUAL MICROSCOPE AND X-RAY INSPECTION OF THE LEAD 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 FRACTURE LOCATION. THE LEAD GOT KINKED AFTER IT EXITS THE CLIK X ANCHOR RESULTING IN THE REPORTED COMPLAINT. 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 IS CAUSE TRACED TO COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT COULD NOT FEEL ANY STIMULATION. ALL CONTACTS ON BOTH LEADS DISPLAYED HIGH IMPEDANCES. AN X-RAY WAS TAKEN WHICH CONFIRMED LEAD PLACEMENT. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE PHYSICIAN REPLACED BOTH LEADS. THE PATIENT WAS STABLE POST-OPERATIVELY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 5092904.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT FEEL ANY STIMULATION. ALL CONTACTS ON BOTH LEADS DISPLAYED HIGH IMPEDANCES. AN X-RAY WAS TAKEN WHICH CONFIRMED LEAD PLACEMENT. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE PHYSICIAN REPLACED BOTH LEADS. THE PATIENT WAS STABLE POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208641 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5092029 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention