BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 18927369 · Received March 18, 2024

    Report

    Report Number
    3006630150-2024-01567
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    January 12, 2024
    Report Date
    March 18, 2024
    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
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R. UPN: (B)(4). MODEL: SC-1160. SERIAL: (B)(6). BATCH: 365884. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: (B)(4). MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 7071664.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF. IT WAS NOTED ALSO THAT LEADS HAD IMPEDANCES AND PATIENT HAD DIFFICULTY CHARGING THE IPG. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2375947 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 7070478 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention