BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE? MRI

    MDR report key: 23089934 · Received September 18, 2025

    Report

    Report Number
    3006630150-2025-07747
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    July 3, 2025
    Report Date
    September 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729995814
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC UPN: M365SC14320 , MODEL: SC-1432, SERIAL: (B)(6), BATCH: 230502, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) PADDLE LEAD HAD MIGRATED OUT OF THE EPIDURAL SPACE DUE TO THE IMPLANTABLE PULSE GENERATOR (IPG) HAD SPUN IN THE POCKET CAUSING THE PATIENT TO EXPERIENCE PAIN. IT WAS NOTED THAT THE DEVICE MIGRATION WAS CONFIRMED THRU X-RAY IMAGING. THE PATIENT UNDERWENT A LEAD REPLACEMENT AND IPG REPOSITIONING PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS KEPT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2841491 COVEREDGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-8436-50 7089429 08714729995814

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention