BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETEK

    MDR report key: 18156823 · Received November 16, 2023

    Report

    Report Number
    3006630150-2023-07125
    Event Type
    Injury
    Date Received
    November 16, 2023
    Date of Event
    September 27, 2023
    Report Date
    November 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820802
    PMA / PMN Number
    P150031
    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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION; UPN: M365DB46000; MODEL: DB-4600; SERIAL: N/A; BATCH: 30042544. PRODUCT FAMILY: DBS-IPG-R-MRI; UPN: M365DB12160; MODEL: DB-1216; SERIAL: (B)(6); BATCH: 563138. PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(6) ; BATCH: 7097940. PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(6); BATCH: 7097968. PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(6); BATCH: 7101893. PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(6); BATCH: 7111512.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SWELLING AND EROSION AT THE DEEP BRAIN STIMULATION (DBS) LEFT BURR-HOLE COVER AND LEAD SITE. CULTURES WERE TAKEN AND TESTED POSITIVE FOR A BACTERIAL INFECTION, HOWEVER THE RESULTS ARE UNAVAILABLE. THE PHYSICIANS ASSESSMENT COULD NOT CONFIRM WHAT CAUSED THE INFECTION HOWEVER NOTED IT WAS NOT DEVICE NOR PROCEDURE RELATED. THE PATIENT UNDERWENT A PROCEDURE WHERE THE LEFT BURR-HOLE COVER AND LEAD WERE REMOVED, IN ADDITION TO THE REMAINING DBS DEVICES PER THE PHYSICIANS PREFERENCE AS A PRECAUTION ON THE POSSIBILITY FOR INFECTION. THE PATIENT WAS PRESCRIBED ANTI-BIOTICS AND DID WELL POST-OPERATIVELY. PHYSICAL ANALYSIS COULD NOT BE PERFORMED IN OUR LABORATORY, AS THE DEVICE WAS RETAINED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981154 SURETEK STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-4600C 30128377 08714729820802

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention