BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 15725897 · Received November 4, 2022

    Report

    Report Number
    3006630150-2022-05962
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    October 1, 2022
    Report Date
    February 17, 2023
    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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: 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: 7073020.

    Additional Manufacturer Narrative · 0

    SC-2317-70. SN: (B)(6). THE RETURNED LEAD WAS ANALYZED AND REVEALED THAT IT WAS SEVERED APPROXIMATELY 24.5 CENTIMETERS FROM THE DISTAL END. THIS WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE. HOWEVER, VISUAL INSPECTION REVEALED SILICONE OVERMOLD CUTS ALONG THE LEAD, AND A PINCH ON THE LEAD WAS OBSERVED NEAR THE PROXIMAL END OF THE CLIK ANCHOR. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT IMPEDANCES ALL OVER THE LEAD WAS CONFIRMED. THE X-RAY EXAMINATION CONFIRMED THAT ALL THE ELECTRODE WIRES WERE FRACTURED AT THE PINCH LOCATION. THE PINCH ON THE LEAD WAS LIKELY CAUSED BY SUTURING DIRECTLY ONTO THE LEAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD HAD IMPEDANCES ALL OVER. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD HAD IMPEDANCES ALL OVER. THE PATIENT UNDERWENT LEAD REPLACEMENT PROCEDURE. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD HAD IMPEDANCES ALL OVER. THE PATIENT UNDERWENT LEAD REPLACEMENT PROCEDURE. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2784008 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5140127 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention