BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 14289319 · Received May 5, 2022

    Report

    Report Number
    3006630150-2022-02046
    Event Type
    Injury
    Date Received
    May 5, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 4, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED TWO DAYS BEFORE SURGERY FROM THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI; UPN: M365SC2408560; MODEL: SC-2408-56; SERIAL: (B)(4); BATCH: 7072295.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD WAS MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693154 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 7072322 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention