BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 19296933 · Received May 13, 2024

    Report

    Report Number
    3006630150-2024-03066
    Event Type
    Injury
    Date Received
    May 13, 2024
    Date of Event
    December 20, 2022
    Report Date
    May 13, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS . UPN: M365SC2317500 . MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 7072184. PRODUCT FAMILY: SCS-LINEAR LEADS . UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7112095.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND STIMULATION IN NON-TARGET AREA. THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE EXPLANTED DEVICES WERE NOT RETURNED DUE TO FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411449 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 3189326 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention