BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 10717625 · Received October 22, 2020

    Report

    Report Number
    3006630150-2020-05085
    Event Type
    Injury
    Date Received
    October 22, 2020
    Date of Event
    September 30, 2020
    Report Date
    October 22, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2316-50E, SERIAL: (B)(4), BATCH: 7103537.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANESTHESIA ADMINISTRATION FOR A TRIAL PROCEDURE, THE PATIENT BEGAN TO VOMIT, SALIVATE AND DISCHARGE NASAL FLUIDS. DURING LEAD INSERTION, THE PATIENT WAS EXPERIENCING UNCOMFORTABLE SENSATIONS IN THE STOMACH. THE PHYSICIAN ABORTED THE PROCEDURE AND THE PATIENT RECOVERED FROM ANESTHESIA. THE EXPLANTED LEADS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183590 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7088298 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention