BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 10185837 · Received June 23, 2020

    Report

    Report Number
    3006630150-2020-02573
    Event Type
    Malfunction
    Date Received
    June 23, 2020
    Date of Event
    March 3, 2020
    Report Date
    June 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
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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-2317-50, SERIAL: (B)(4), BATCH: 7015358. SC-2317-50 (SN (B)(4)). THE RETURNED LEADS WERE ANALYZED AND INSPECTION REVEALED THAT ALL CABLES WERE COMPLETELY BROKEN AT THE BENT OR KINKED LOCATION OF THE LEADS BUT THERE WERE NO EXPOSED CABLES AT THE FRACTURE LOCATION. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED ALLEGATION OF THE PATIENT LOSING STIMULATION AND HIGH IMPEDANCE WAS CONFIRMED. THE LEADS WERE 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT FEELING ANY STIMULATION AS ALL CONTACTS EXHIBITED HIGH IMPEDANCES ON BOTH LEADS. LEAD MIGRATION WAS CONFIRMED THROUGH FLUOROSCOPY. IT WAS NOTED THAT THE PATIENT CAUGHT AN ELK HEAD FALLING OUT OF THE BACK OF A PICKUP TRUCK. THE PHYSICIAN AGREED THAT THE LEADS DID NOT FAIL PREMATURELY. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE LEADS WERE RETURNED FOR ANALYSIS WHICH CONFIRMED THAT THE LEADS WERE FRACTURED. THIS COULD HAVE CAUSED THE REPORTED CLINICAL OBSERVATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647930 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5038165 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention