BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE? 32

    MDR report key: 22671292 · Received July 30, 2025

    Report

    Report Number
    3006630150-2025-05990
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    May 20, 2025
    Report Date
    September 2, 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
    PA, 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-PC. UPN: M365SC14320. MODEL: SC-1432. SERIAL: (B)(6). BATCH: 232559. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INFECTION DUE TO THE THORACIC INCISION HAD WOUND DEHISCENCE. IT WAS NOTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT WAS PRESCRIBED WITH KEFLEX AND BACTRIM FOR THE INFECTION. ACCORDING TO THE PHYSICIAN THE INFECTION WAS DUE TO A BURIED SUTURE AND WAS NOT CAUSED BY ANY OF THE SPINAL CORD STIMULATOR (SCS) DEVICES. THE INCISION WOUND HAD HEALED WELL. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INFECTION DUE TO THE THORACIC INCISION HAD WOUND DEHISCENCE. IT WAS NOTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT WAS PRESCRIBED WITH KEFLEX AND BACTRIM FOR THE INFECTION. ACCORDING TO THE PHYSICIAN THE INFECTION WAS DUE TO A BURIED SUTURE AND WAS NOT CAUSED BY ANY OF THE SPINAL CORD STIMULATOR (SCS) DEVICES. THE INCISION WOUND HAD HEALED WELL. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE DISPOSED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496643 COVEREDGE? 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-8336-70 7077162 08714729832676

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention