BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 20192170 · Received September 11, 2024

    Report

    Report Number
    3006630150-2024-06037
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    August 20, 2024
    Report Date
    September 11, 2024
    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: 7243935.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WOKE UP WITH EXCRUCIATING PAIN IN THE LEFT FOOT, FOLLOWING A TRIAL PROCEDURE. THE PAIN WAS SO SEVERE THAT MEDICATION WOULD NOT TREAT. THE PATIENT HAD A SPINAL CORD STIMULATION (SCS) LEAD PULL, AND THE EXPLANTED LEADS WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021618 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7241668 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention