BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETEK

    MDR report key: 19555707 · Received June 18, 2024

    Report

    Report Number
    3006630150-2024-03908
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 23, 2024
    Report Date
    June 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820802
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT UNKNOWN. APPROXIMATED BASED ON THE MANUFACTURER BECOMING AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A. BATCH: 32118928. PRODUCT FAMILY: DBS-IPG-R-MRI. UPN: M365DB12160. MODEL: DB-1216. SERIAL: (B)(6). BATCH: 578509. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7110982. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL:(B)(6). BATCH: 7110968. PRODUCT FAMILY: UPN: M365NM313550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7119603. PRODUCT FAMILY: UPN: M365NM313550. MODEL: NM-3138-55 SERIAL: (B)(6). BATCH: 7120227.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED DEHISCENCE AND IRRITATION AT THE DEEP BRAIN STIMULATION (DBS) BURR-HOLE COVER IMPLANT SITE. IT WAS NOTED THE INCISION WAS NOT HEALING PROPERLY AND SCALPS BURR-HOLE COVER ERODED, IN ADDITION MAY HAVE BEEN IRRITATED BY THE PATIENT PER THE PHYSICIANS ASSESSMENT. THE PATIENT UNDERWENT A PROCEDURE WHERE THE WHOLE DBS SYSTEM WAS REMOVED. CULTURES WERE NOT TAKEN, AND INFECTION WAS NOT CONFIRMED HOWEVER THE PATIENT WAS PRESCRIBED ANTI-BIOTICS. PHYSICAL ANALYSIS OF THE DBS SYSTEM WAS NOT PERFORMED AS IT WAS DISPOSED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072022 SURETEK STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-4600C 32118928 08714729820802

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention