BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE? 32

    MDR report key: 22323327 · Received June 24, 2025

    Report

    Report Number
    3006630150-2025-04816
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    May 14, 2025
    Report Date
    June 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729832669
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED THREE WEEKS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC, UPN: M365SC14320, MODEL: SC-1432, SERIAL: (B)(6), BATCH: 233618, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS PADDLE LEAD HAD MIGRATED WHICH WAS CONFIRMED THROUGH X-RAY. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE PADDLE LEAD AND IPG WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE NOT RELEASED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997486 COVEREDGE? 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-8336-50 7088468 08714729832669

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention