BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVISTA? MRI

    MDR report key: 22109631 · Received May 29, 2025

    Report

    Report Number
    3006630150-2025-03769
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 9, 2025
    Report Date
    November 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: 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: 19007820, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR (SCS) LEAD WAS FRACTURED. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT UNDERWENT A SCS LEADS EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED COMPONENTS WERE DISCARDED PER FACILITY POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD WAS FRACTURED. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709214 AVISTA? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2408-56 19007820 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention