BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 16432359 · Received February 23, 2023

    Report

    Report Number
    3006630150-2023-00804
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    February 1, 2023
    Report Date
    February 23, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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-231650E, SERIAL: (B)(4), BATCH: 7182325.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRIAL, THE PATIENT HAD A PANIC ATTACK WHEN FEELING THE STIMULATION. THE PATIENT UNDERWENT A LEAD PULL AND THE PATIENT WAS DOING WELL AFTER. THE REMOVED LEADS WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444563 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7182080 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention