BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 13083308 · Received December 24, 2021

    Report

    Report Number
    3006630150-2021-07230
    Event Type
    Injury
    Date Received
    December 24, 2021
    Date of Event
    September 7, 2021
    Report Date
    December 24, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408740, MODEL: SC-2408-74, SERIAL: (B)(4), BATCH: 7070190. PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12000, MODEL: SC-1200, SERIAL: (B)(4), BATCH: 364706.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE LEAD INSERTION SITE AND FELT THAT THE SPINAL CORD STIMULATOR (SCS) WAS NOT PROVIDING ADEQUATE PAIN RELIEF. IT WAS NOTED THAT THE SCS WAS CAUSING MORE PAIN THAN PAIN RELIEF. THE PATIENT UNDERWENT AN SCS SYSTEM EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1981912 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 5173627 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention