BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 20525144 · Received October 24, 2024

    Report

    Report Number
    3006630150-2024-07284
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    April 19, 2024
    Report Date
    October 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED TWO WEEKS FROM THE DATE 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)(6) BATCH: 5152934.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING LOSS OF STIMULATION DUE TO HIGH IMPEDANCES AND SPINAL CORD STIMULATION (SCS) LEAD FRACTURE FOLLOWING A NON-DEVICE RELATED FALL. THE PATIENT UNDERWENT AN SCS LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICES WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737624 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 5147047 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention