BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 16572755 · Received March 20, 2023

    Report

    Report Number
    3006630150-2023-01369
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    May 9, 2022
    Report Date
    March 20, 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
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7072094.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED HIGH IMPEDANCES. THE SYSTEM WAS REPROGRAMMED, AND ADEQUATE THERAPY WAS PROVIDED. LATER, ADDITIONAL HIGH IMPEDANCES WERE OBSERVED, AND AN X-RAY WAS PERFORMED. DEVICE PROGRAMMING COULD NOT REGAIN COVERAGE OF THE PAIN AREAS. THE PATIENT UNDERWENT A LEAD REPLACEMENT OF BOTH LEADS. POST-OPERATIVELY THE PATIENT EXPERIENCED NUMBNESS BUT IT IS RESOLVING ON ITS OWN. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713901 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7073396 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention