BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE 32

    MDR report key: 12425289 · Received September 3, 2021

    Report

    Report Number
    3006630150-2021-04960
    Event Type
    Injury
    Date Received
    September 3, 2021
    Date of Event
    August 12, 2021
    Report Date
    September 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729832676
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138550, MODEL: SC-3138-55, SERIAL: (B)(4), BATCH: 7040254/7082172/7085618/7085694.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE MIDLINE INCISION SITE AS WELL AS THE LEFT FLANK WHERE THE EXTENSIONS WERE EXITING THE SKIN. OOZING OF THE FLUID WAS ALSO NOTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT WAS HOSPITALIZED AND WAS PLACED ON ANTIBIOTICS. THE PHYSICIAN FLUSHED THE INCISION OUT AND ALL COMPONENTS WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WILL NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317688 COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8336-70 7071480 08714729832676

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R