BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 11818967 · Received May 13, 2021

    Report

    Report Number
    3006630150-2021-02096
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 3, 2021
    Report Date
    May 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC231650E0, MODEL: SC-2316-50E, SERIAL: (B)(4), BATCH: 7113093.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FAILED TRIAL DUE TO CRAMPING PAIN IN THE CHEST UNDER LEFT ARM AND UPPER BACK. THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM AND IT WAS DETERMINED THAT THE SPASM WAS CAUSED BY PATIENTS ANXIETY. THE PATIENT WAS GIVEN MEDICINE FOR ANXIETY. THE EXPLANTED TRIAL LEADS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716881 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7110717 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention