BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 17652300 · Received August 30, 2023

    Report

    Report Number
    3006630150-2023-05186
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    March 1, 2023
    Report Date
    September 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(6); BATCH: 7109188. PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(6); BATCH: 7090199. PRODUCT FAMILY: DBS-LEAD FIXATION; UPN: M365DB4600C0; MODEL: DB-4600C; SERIAL: N/A; BATCH: 28996647.

    Additional Manufacturer Narrative · 0

    CORRECTION TO BLOCK H6: IMPACT CODES. BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: (B)(6). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: (B)(6). PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 28996647.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN INFECTION AT THE RETROMASTOID AREA. THE PATIENTS INFECTION HAD PUSS SEEPING OUT AND IT WAS NOTED THAT THE INFECTION WAS CAUSED BY THE CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) MACHINE RUBBING AGAINST THE LEAD/EXTENSION CONNECTOR. NOTHING OCCURRED IN THE PATIENTS RECENT PROCEDURE THAT MAY HAVE CAUSED THE INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR FOUR MONTHS. A CULTURE WAS PERFORMED, BUT RESULTS COULD NOT BE OBTAINED DESPITE GOOD FAITH EFFORTS. THE MEDICAL FACILITY RETAINED ALL EXPLANTED PRODUCTS AND THEY WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN INFECTION AT THE RETROMASTOID AREA. THE PATIENTS INFECTION HAD PUSS SEEPING OUT AND IT WAS NOTED THAT THE INFECTION WAS CAUSED BY THE CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) MACHINE RUBBING AGAINST THE LEAD/EXTENSION CONNECTOR. NOTHING OCCURRED IN THE PATIENTS RECENT PROCEDURE THAT MAY HAVE CAUSED THE INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR FOUR MONTHS. A CULTURE WAS PERFORMED, BUT RESULTS COULD NOT BE OBTAINED DESPITE GOOD FAITH EFFORTS. THE MEDICAL FACILITY RETAINED ALL EXPLANTED PRODUCTS AND THEY WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493279 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 533268 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention