BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 16087835 · Received January 3, 2023

    Report

    Report Number
    3006630150-2022-07452
    Event Type
    Injury
    Date Received
    January 3, 2023
    Date of Event
    October 10, 2022
    Report Date
    January 3, 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
    MO, 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: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(4). BATCH: 5132505.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED INADEQUATE STIMULATION DESPITE OF MULTIPLE REPROGRAMMING ATTEMPTS AND LEADS HAD UNUSABLE HIGH IMPEDANCES. THE 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
    132282 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5132502 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention