BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 14548289 · Received May 31, 2022

    Report

    Report Number
    3006630150-2022-02595
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    July 1, 2021
    Report Date
    May 4, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729904823
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. 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: 7071846. PRODUCT FAMILY: SCS-LEAD FIXATION-MRI. UPN: M365SC43190. MODEL: SC-4319. SERIAL: N/A. BATCH: 24001104.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF FROM THE SPINAL CORD STIMULATION (SCS) SYSTEM. THE PHYSICIAN ASSESSED THAT THE PATIENT'S SCOLIOSIS AND SCAR TISSUE PREVENTED OPTIMAL LEAD PLACEMENT WHICH THEREFORE, CAUSED INADEQUATE PAIN RELIEF. THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE BOTH IMPLANTED LEADS WERE EXPLANTED AND REPLACED WITH TWO NEW LEADS. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. THE PATIENT WAS DOING FINE POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515393 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2408-74 5161644 08714729904823

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention