BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? 16

    MDR report key: 25308334 · Received May 27, 2026

    Report

    Report Number
    3006630150-2026-03539
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    January 22, 2026
    Report Date
    May 27, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729837145
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2316-70E. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7092728. MODEL/CATALOG DESCRIPTION: 1X16 PERC LEAD TRIAL KIT, 70 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF CONSCIOUSNESS (SYNCOPE). THE PATIENT UNDERWENT TRIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429125 INFINION? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2316-70E 7092879 08714729837145

    Patients

    Seq Age Sex Outcome Treatment
    1