BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 10299566 · Received July 20, 2020

    Report

    Report Number
    3006630150-2020-03007
    Event Type
    Injury
    Date Received
    July 20, 2020
    Date of Event
    July 2, 2020
    Report Date
    July 20, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 5152084. PRODUCT FAMILY: SCS-IPG-R, UPN: (B)(4), MODEL: SC-1160, SERIAL: (B)(4), BATCH: 349652.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A STAPHYLOCOCCUS AUREUS INFECTION AT THE INCISION SITE. IT WAS NOTED THAT THE INFECTED SITE HAD A WOUND AND THE PATIENTS WHITE BLOOD CELLS WERE ELEVATED. THE PHYSICIAN CONFIRMED THAT THE PATIENT WAS PREDISPOSED TO GETTING INFECTIONS AND THAT THE INFECTION WAS NOT DEVICE RELATED. DURING THE PROCEDURE, THE INFECTED TISSUE WAS DISCOVERED TO BE AROUND THE LEAD. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. ALL DEVICE COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763056 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5138183 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention