BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 19210295 · Received April 29, 2024

    Report

    Report Number
    3006630150-2024-02722
    Event Type
    Injury
    Date Received
    April 29, 2024
    Date of Event
    April 9, 2024
    Report Date
    April 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON 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)(6) BATCH: 7081664 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI UPN: M365SC12160 MODEL: SC-1216 SERIAL: (B)(6) BATCH: 592828.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT POCKET INCISION WAS NOT FULLY CLOSED. IT WAS NOTED THAT PATIENT HAD AN INFECTION AND THERE WAS NO OBVIOUS INFECTION OR WITH MICROBIO TESTING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE ALL DEVICES WAS REMOVED AND WILL NOT BE RETURN PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080463 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 7081159 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention