BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETEK

    MDR report key: 11419242 · Received March 5, 2021

    Report

    Report Number
    3006630150-2021-00771
    Event Type
    Injury
    Date Received
    March 5, 2021
    Date of Event
    February 12, 2021
    Report Date
    March 4, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820802
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7078936. PRODUCT FAMILY: DBS-EXTENSION, UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7082485. PRODUCT FAMILY: DBS-EXTENSION, UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7083279.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SECOND STAGE OF THE DEEP BRAIN STIMULATION IMPLANT PROCEDURE THE PHYSICIAN NOTICED THAT THE ORIGINAL LEFT SIDED BURR HOLE INCISION LOOKED A LITTLE RED AND SWOLLEN. THE PHYSICIAN PRESSED ON THE INCISION AND A YELLOW LIQUID WAS PRESENT AND LEAKING FROM THE SITE. THE PHYSICIAN REMOVED THE BURR HOLE COVER, THE LEAD, AND BOTH EXTENSIONS AND CULTURED THE SITE. THE CULTURE CAME BACK POSITIVE FOR AN INFECTION. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON IV ANTIBIOTICS AND WAS NOTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316741 SURETEK STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-4600C 26408408 08714729820802

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention