BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 10819766 · Received November 10, 2020

    Report

    Report Number
    3006630150-2020-05461
    Event Type
    Injury
    Date Received
    November 10, 2020
    Date of Event
    March 1, 2020
    Report Date
    November 10, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), LOT: 7070351.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED NO PAIN COVERAGE WITH SOME PAIN AND DISCOMFORT FROM STIMULATION ON THE RIGHT LEAD. AN X-RAY WAS DONE AND CONFIRMED ONE LEAD HAD MIGRATED OUTSIDE OF THE EPIDURAL SPACE, AND THE OTHER LEAD WAS LYING HORIZONTALLY NEAR THE ANCHORS. PATIENT UNDERWENT A REVISION PROCEDURE TO REPOSITION THE LEADS. PATIENT IS DOING WELL POST-OPERATIVELY AND PAIN COVERAGE WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280231 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 3174050 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention