BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINION 16

    MDR report key: 11276054 · Received February 3, 2021

    Report

    Report Number
    3006630150-2021-00240
    Event Type
    Death
    Date Received
    February 3, 2021
    Date of Event
    January 16, 2021
    Report Date
    February 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M364SC231650E0, MODEL: SC-2316-50E, SERIAL: (B)(4), BATCH: 7112598.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY A DAY AFTER HAVING THE TRIAL LEADS PLACED. THE PATIENT WAS NOT ABLE TO BE SEDATED FOR THE TRIAL PROCEDURE BECAUSE HIS BLOOD PRESSURE AND OXYGEN WERE LOW. HIS OXYGEN REMAINED LOW IN PACU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171304 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7112518 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death