BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE? 32

    MDR report key: 23733487 · Received December 5, 2025

    Report

    Report Number
    3006630150-2025-11233
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    November 1, 2024
    Report Date
    May 11, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729832676
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC14320. MODEL: SC-1432. SERIAL: (B)(6). BATCH: 220906. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION. IT WAS DISCOVERED PER X-RAY THAT THE PADDLE LEAD HAD DISLODGED OUT OF THE EPIDURAL SPACE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366705 COVEREDGE? 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-8336-70 7074124 08714729832676

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention