BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 13677550 · Received March 5, 2022

    Report

    Report Number
    3006630150-2022-00863
    Event Type
    Injury
    Date Received
    March 5, 2022
    Date of Event
    February 11, 2022
    Report Date
    March 4, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904823
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: 7070765.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION IN THE NON-TARGET PAIN AREA OF THE LEFT RIBS. X-RAY IMAGES TAKEN IN THE FIELD REVEALED THE LEADS HAD MIGRATED LATERALLY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE REPOSITIONED. THE PATIENT DID WELL POST-OPERATIVELY AND NO LONGER EXPERIENCED STIMULATION IN THE LEFT RIBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2569290 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-74 7070878 08714729904823

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention