BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 11229160 · Received January 26, 2021

    Report

    Report Number
    3006630150-2021-00143
    Event Type
    Injury
    Date Received
    January 26, 2021
    Date of Event
    January 6, 2021
    Report Date
    January 26, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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: (B)(4), MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 7071541.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS PUT BACK IN PROPER LOCATION TO COVER THE PAIN AREA. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NOTHING WAS IMPLANTED OR EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129031 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 7071499 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention