BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVEREDGE? 32

    MDR report key: 22527220 · Received July 16, 2025

    Report

    Report Number
    3006630150-2025-05580
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 23, 2025
    Report Date
    July 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729832676
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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-R-MRI, UPN: M365SC12320, MODEL: SC-1232, SERIAL: (B)(6), BATCH: 791759, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE NEURAL MONITORING PERSONNEL NOTED THAT THE PATIENT LOST SENSORY AND MOTORS ON THE RIGHT LEG WHEN THE PROCEDURE WAS ALMOST DONE. TROUBLESHOOTING STEPS WERE DONE HOWEVER THE ISSUES WERE NOT RESOLVED. THE PHYSICIAN OPENED THE MIDLINE INCISION AND REMOVED THE PADDLE LEAD, AND SEVERAL MINUTES LATER, THE SENSORS WERE GETTING A READING AGAIN. THE PHYSICIAN OPTED TO ABORT THE CASE AND REMOVE ALL DEVICE COMPONENTS. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. THE EXPLANTED DEVICES WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647053 COVEREDGE? 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-8336-70 7076887 08714729832676

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention