BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 20527693 · Received October 24, 2024

    Report

    Report Number
    3006630150-2024-07288
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    October 7, 2024
    Report Date
    October 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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: 7253073.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED DUE TO A HEART ATTACK. THE PATIENTS SPINAL CORD TRIAL STIMULATOR LEADS WERE EXPLANTED AND WILL NOT BE RETURN. THE PATIENT WAS SENT TO CARDIAC REHAB FACILITY FOR MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565188 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2316-50E 7253204 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention