BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE? 32

    MDR report key: 22582515 · Received July 23, 2025

    Report

    Report Number
    3006630150-2025-05789
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729832669
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT. PRODUCT FAMILY SCS-EXTENSION: UPN M365SC3138550. MODEL SC-3138-55. SERIAL-LOT (B)(6). BATCH 7138913. UPN (B)(4). PRODUCT FAMILY SCS-EXTENSION: UPN M365SC3138550. MODEL SC-3138-55. SERIAL-LOT (B)(6). BATCH 7140195. UPN (B)(4). PRODUCT FAMILY SCS-EXTENSION: UPN M365SC3138550. MODEL SC-3138-55. SERIAL-LOT (B)(6). BATCH 7140065. UPN (B)(4). PRODUCT FAMILY SCS-EXTENSION: UPN M365SC3138550. MODEL SC-3138-55. SERIAL-LOT (B)(6). BATCH 7140246. UPN (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT PRODUCT FAMILY SCS-EXTENSION. UPN M365SC3138550. MODEL SC-3138-55. SERIAL-LOT (B)(6). BATCH (B)(6). UPN (B)(4). PRODUCT FAMILY SCS-EXTENSION UPN M365SC3138550. MODEL SC-3138-55. SERIAL-LOT (B)(6). BATCH (B)(6). UPN (B)(4). PRODUCT FAMILY SCS-EXTENSION. UPN M365SC3138550. MODEL SC-3138-55. SERIAL-LOT (B)(6). BATCH (B)(6). UPN (B)(4). PRODUCT FAMILY SCS-EXTENSION. UPN M365SC3138550. MODEL SC-3138-55. SERIAL-LOT (B)(6). BATCH (B)(6). UPN (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SPINAL CORD STIMULATION (SCS) PERMANENT TRIAL PERIOD, THE PATIENT EXPERIENCED WEAKNESS IN HIS LEGS AND PAIN IN HIS STOMACH WHEN HE TOUCHED IT. THE PATIENT WAS HOSPITALIZED AND UNDERWENT A PROCEDURE IN WHICH THE TRIAL PADDLE LEAD AND LEAD EXTENSIONS WERE EXPLANTED. DURING THE EXPLANT PROCEDURE, THE PHYSICIAN NOTED SOME BLOOD CLOTTING IN THE EPIDURAL SPACE WHICH WAS EVACUATED. THE PHYSICIAN COMPLETED A LAMINECTOMY AT THORACIC 7-8 AND INSERTED A DRAIN TO HELP RELIEVE PRESSURE IN THIS AREA. THE PATIENT IS GOING TO STAY IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. THE EXPLANTED DEVICES WILL NOT BE RETURNED PER FACILITY PROTOCOL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SPINAL CORD STIMULATION (SCS) PERMANENT TRIAL PERIOD THE PATIENT EXPERIENCED WEAKNESS IN HIS LEGS AND PAIN IN HIS STOMACH WHEN HE TOUCHED IT. THE PATIENT WAS HOSPITALIZED AND UNDERWENT A PROCEDURE IN WHICH THE TRIAL PADDLE LEAD AND LEAD EXTENSIONS WERE EXPLANTED. DURING THE EXPLANT PROCEDURE THE PHYSICIAN NOTED SOME BLOOD CLOTTING IN THE EPIDURAL SPACE WHICH WAS EVACUATED. THE PHYSICIAN COMPLETED A LAMINECTOMY AT THORACIC 7-8 AND INSERTED A DRAIN TO HELP RELIEVE PRESSURE IN THIS AREA. THE PATIENT IS GOING TO STAY IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. THE EXPLANTED DEVICES WILL NOT BE RETURNED PER FACILITY PROTOCOL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAS REGAINED FULL STRENGTH HOWEVER EXPERIENCED SOME RESIDUAL PAIN IN HIS ABDOMEN, WHICH THE PHYSICIAN BELIEVES MAY HAVE BEEN DUE TO IRRITATION FROM THE PADDLE LEAD. IT WAS REPORTED THAT THE PAIN SHOULD IMPROVE WITH TIME. THERE IS NO FURTHER COURSE OF ACTION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2187801 COVEREDGE? 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-8336-50 7089495 08714729832669

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R