BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE 32

    MDR report key: 19639344 · Received June 28, 2024

    Report

    Report Number
    3006630150-2024-04192
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    April 1, 2024
    Report Date
    July 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729832669
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN APRIL 2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC UPN: M365SC14320 MODEL: SC-1432 SERIAL: (B)(6) BATCH: 211807.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A STAPHYLOCOCCUS AUREUS INFECTION AT THE LEAD INCISION SITE, WHICH WAS CONFIRMED BY CULTURE TEST. SYMPTOM OF PUSS UNDER THE SKIN WAS NOTED. IT WAS ALSO MENTIONED THAT THE IPG WAS NO LONGER WORKING AS INTENDED. THE PATIENT WAS TREATED WITH VANCOMYCIN POWDER AND ORAL ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG AND LEAD WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A STAPHYLOCOCCUS AUREUS INFECTION AT THE LEAD INCISION SITE, WHICH WAS CONFIRMED BY CULTURE TEST. SYMPTOM OF PUSS UNDER THE SKIN WAS NOTED. IT WAS ALSO MENTIONED THAT THE IPG WAS NO LONGER WORKING AS INTENDED. THE PATIENT WAS TREATED WITH VANCOMYCIN POWDER AND ORAL ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG AND LEAD WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS INFECTION WAS NOT PROCEDURE RELATED, HOWEVER, IT WAS UNKNOWN IF IT WAS DEVICE RELATED. IT WAS ALSO NOTED THAT AN ELECTIVE REPLACEMENT INDICATOR MESSAGE WAS RECEIVED ON THE REMOTE CONTROL (RC), HOWEVER, IT WAS NOT DETERMINED IF THE PATIENT WAS A HIGH FREQUENCY USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2214966 COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8336-50 21072099 08714729832669

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention