BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE 32

    MDR report key: 21610618 · Received March 14, 2025

    Report

    Report Number
    3006630150-2025-01535
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 20, 2023
    Report Date
    March 14, 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
    NV, US
    Reporter Occupation
    OTHER

    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: 210342.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT THEY WERE CRIPPLED AFTER THE SPINAL CORD STIMULATOR (SCS) IMPLANT PROCEDURE AND THAT IT DID NOT PROVIDE STIMULATION. PATIENT WAS IN REHABILITATION FOR 16 WEEKS. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCS SYSTEM WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641922 COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-8336-70 7073281 08714729832676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention