BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 16308987 · Received February 6, 2023

    Report

    Report Number
    3006630150-2023-00422
    Event Type
    Injury
    Date Received
    February 6, 2023
    Date of Event
    November 27, 2022
    Report Date
    March 9, 2023
    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
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: 7072583.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN PATIENT LAID DOWN, THE STIMULATION GOT STRONG FOR A COUPLE SECONDS AND THEN STOPPED. THE PATIENT TURNED UP STIMULATION AND WAS NOT ABLE TO FEEL SENSATION. IT WAS ALSO REPORTED THAT PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENTS LEADS HAD HIGH IMPEDANCES AND WERE FRACTURED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN PATIENT LAID DOWN, THE STIMULATION GOT STRONG FOR A COUPLE SECONDS AND THEN STOPPED. THE PATIENT TURNED UP STIMULATION AND WAS NOT ABLE TO FEEL SENSATION. IT WAS ALSO REPORTED THAT PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENTS LEADS HAD HIGH IMPEDANCES AND WERE FRACTURED. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE KEPT BY FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327894 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 7072558 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention