BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETEK

    MDR report key: 19327187 · Received May 15, 2024

    Report

    Report Number
    3006630150-2024-03149
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    April 15, 2024
    Report Date
    May 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820802
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI UPN: M365DB12160 MODEL: DB-1216 SERIAL: (B)(6) BATCH: 596363. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 7115276. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 7113627.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT CONTACTED HER PHYSICIAN AS SHE WAS CONCERNED THAT HER INCISION SITE WAS RED AND SWOLLEN. THE PHYSICIAN ASSESSED HER INCISION SITE AND DETERMINED THAT IT WAS IRRITATED. ON THAT DATE, THE PATIENT UNDERWENT A WOUND WASHED OUT WHERE THEY WERE ADMINISTERED ANTIBIOTICS. A CULTURE WAS TAKEN THAT REVEALED THAT THE PATIENT HAD DEVELOPED STAPHYLOCOCCUS AT THE BURR HOLE SITES. FOUR DAYS FOLLOWING THE WOUND WASHOUT PROCEDURE THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE HER DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND IS DOING WELL POST-OPERATIVELY. THE DEVICES WERE DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475150 SURETEK STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-4600C 31754619 08714729820802

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention