BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 18390563 · Received December 25, 2023

    Report

    Report Number
    3006630150-2023-08119
    Event Type
    Injury
    Date Received
    December 25, 2023
    Date of Event
    December 4, 2023
    Report Date
    December 25, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: M365SC231650E0, MODEL: SC-2316-50E, SERIAL: (B)(6), BATCH: 7222629.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE TRIAL PROCEDURE, THE PATIENT EXPERIENCED PAIN AT THE INSERTION SITE OF THE TRIAL LEADS. THE PATIENT WAS GIVEN POST OPERATIVE MEDICATION WITHOUT RELIEF. THE PATIENT UNDERWENT AN EARLY LEAD PULL. THE EXPLANTED PRODUCT WILL NOT BE RETURNED DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308514 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7221023 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention