BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 17715760 · Received September 8, 2023

    Report

    Report Number
    3006630150-2023-05436
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    March 24, 2023
    Report Date
    October 26, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3128550. MODEL: DB-3128-55. SERIAL: (B)(6). BATCH: 5001508.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3128550. MODEL: DB-3128-55. SERIAL: (B)(6). BATCH: 5001508.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO MONTHS POST-IMPLANT PROCEDURE THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED A WOUND INFECTION AT THEIR IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THE PATIENT'S WOUND WAS WASHED OUT AND THEY WERE ADMINISTERED INTRAVENOUS (IV) AND ORAL ANTIBIOTICS, HOWEVER, THE REPORTED ISSUE PERSISTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE IPG AND EXTENSION WERE EXPLANTED. THE PATIENT IS DOING WELL POST-OPERATIVELY. THE DEVICES WERE DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD BEEN READMITTED TO THE HOSPITAL FOR THE WOUND WASHOUT AND WAS ON ANTIBIOTICS FOR THREE MONTHS. A CULTURE REVEALED THE PATIENT HAD STAPHYLOCOCCUS AUREUS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO MONTHS POST-IMPLANT PROCEDURE THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED A WOUND INFECTION AT THEIR IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THE PATIENT'S WOUND WAS WASHED OUT AND THEY WERE ADMINISTERED INTRAVENOUS (IV) AND ORAL ANTIBIOTICS, HOWEVER, THE REPORTED ISSUE PERSISTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE IPG AND EXTENSION WERE EXPLANTED. THE PATIENT 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
    1242925 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 542876 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention