BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 11825440 · Received May 14, 2021

    Report

    Report Number
    3006630150-2021-02123
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    March 15, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED TWO DAYS AFTER IMPLANT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEAD-MRI, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 7073118. PRODUCT FAMILY: SCS-IPG-R-MRI: UPN: M365SC12160, MODEL: SC-1216, SERIAL: (B)(4), BATCH: 505712.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD MIGRATED POST IMPLANT PROCEDURE. THE PATIENT WAS FEELING STIMULATION ON HER URINARY BLADDER AND MENTIONED THAT THE SPINAL CORD STIMULATOR WAS MAKING HER PSYCHOLOGICALLY DEPRESSED. ALL DEVICE COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725524 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 7073099 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention