BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 8667355 · Received June 4, 2019

    Report

    Report Number
    3006630150-2019-02606
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 16, 2019
    Report Date
    June 4, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5132122, MODEL/CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A TRIAL PROCEDURE THE PATIENT WAS EXPERIENCING TREMENDOUS FOOT PAIN AND FOOT DROP. THE PHYSICIAN BELIEVED IT WAS PROCEDURAL PAIN AND SUSPECTED A NERVE ROOT GOT "DINGED" EITHER DUE TO NEEDLE ENTRY OR LATERAL AND ANTERIOR DRIVING OF THE LEAD. THE LEAD WAS PULLED, AND MAGNETIC RESONANCE IMAGING WAS TAKEN WITH NO REMARKABLE DAMAGED ACCORDING TO THE PHYSICIAN. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461669 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 5121299 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention