BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 16095625 · Received January 4, 2023

    Report

    Report Number
    3006630150-2022-07474
    Event Type
    Injury
    Date Received
    January 4, 2023
    Date of Event
    July 18, 2022
    Report Date
    January 4, 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
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: EXACT DATE UNKNOWN, EVENT OCCURRED IN THE PAST TWO WEEKS FROM 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: 5141471.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT LOST STIMULATION COVERAGE AND WAS NOT GETTING AN ADEQUATE PAIN RELIEF DESPITE REPROGRAMMING DONE DUE TO HIGH IMPEDANCES ON THE LEFT LEAD. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118704 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5141107 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention