BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 16855145 · Received May 2, 2023

    Report

    Report Number
    3006630150-2023-02429
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    February 8, 2023
    Report Date
    May 26, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: 7190697.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING SEVERE PAIN DUE TO AN UNKNOWN COMPLICATION DURING THE TRIAL PROCEDURE. THE PATIENT WAS ADVISED TO TAKE EXTRA PAIN MEDICATION. THE PATIENT COMPLETED THE TRIAL, AND THE LEADS WERE PULLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING SEVERE PAIN DUE TO AN UNKNOWN COMPLICATION DURING THE TRIAL PROCEDURE. THE PATIENT WAS ADVISED TO TAKE EXTRA PAIN MEDICATION. THE PATIENT COMPLETED THE TRIAL, AND THE LEADS WERE PULLED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE TRIAL LEADS WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636321 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7190508 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention