BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 21405685 · Received February 18, 2025

    Report

    Report Number
    3006630150-2025-00841
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 15, 2025
    Report Date
    February 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729837145
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC231670E0, MODEL: SC-2316-70E, SERIAL: (B)(6), BATCH: 7090256.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING AN EARLY LEAD PULL PROCEDURE, THE PATIENT WAS IN AND OUT OF CONSCIOUSNESS AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE CAUSE OF THE MEDICAL ISSUE WAS UNKNOWN. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44243 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2316-70E 7091464 08714729837145

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention