BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 20584751 · Received October 31, 2024

    Report

    Report Number
    3006630150-2024-07463
    Event Type
    Injury
    Date Received
    October 31, 2024
    Date of Event
    September 30, 2024
    Report Date
    March 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: BS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6) . BATCH: 7131383. PRODUCT FAMILY: BS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7131407. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7110163. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7115358. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A. BATCH: 33029844. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: (B)(6). BATCH: 33162397. DEVICE TECHNICAL ANALYSIS OF ALL DEVICES: THE RETURNED VERCISE GENUS IPG AND IMPLANTABLE DEVICES WERE ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE REPORTED EVENT WAS NOT CONFIRMED SINCE THERE IS NO ALLEGATION AGAINST THE FUNCTIONALITY OF THE DEVICES. A PRODUCT LABELING REVIEW DID NOT REVEAL ANY ANOMALIES. ADDITIONALLY, THE INSTRUCTIONS FOR USE (IFU) STATES INFECTION IS A KNOWN RISK OF IMPLANTING AN IMPLANTABLE PULSE GENERATOR (IPG) AS PART OF A SYSTEM TO DELIVER DEEP BRAIN STIMULATION, INCLUDING, SWELLING OR BRUISING OF THE MUSCLES OR SKIN IN THE AREA OF THE IMPLANTED DEVICES, AS WELL AS, BRAIN OR CEREBRAL SPINAL FLUID (CSF) FLUID INFECTION OR INFLAMMATION, SWELLING, INCLUDING FLUID COLLECTING AROUND THE DEVICE, IMPLANTED DEVICE COMPONENTS MAY MOVE FROM ORIGINAL IMPLANTED LOCATION OR WEAR THROUGH THE SKIN, WHICH MAY LEAD TO THE NEED FOR ADDITIONAL SURGERY, TEMPORARY PAIN AT THE IMPLANT SITE, DURING THE TWO WEEKS FOLLOWING SURGERY IT IS IMPORTANT THAT PATIENTS USE EXTREME CARE SO THAT APPROPRIATE HEALING WILL SECURE THE IMPLANTED COMPONENTS AND CLOSE THE SURGICAL INCISIONS ARE A KNOWN INHERENT RISK OF DEVICE AS DOCUMENTED IN THE IFU. THEREFORE, ENGINEERS CONCLUDED THAT THE PROBABLE CAUSE OF KNOWN INHERENT RISK OF DEVICE.

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT BETWEEN (B)(6) 2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: BS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6) BATCH: 7131383. PRODUCT FAMILY: BS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: 7131407 BATCH: 7131407. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 7110163. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 7115358. PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600C SERIAL: N/A BATCH: 33029844. PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600C SERIAL: N/A BATCH: 33162397.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED REDNESS, INFLAMMATION AND IMPAIRED HEALING AT THE IMPLANTABLE PULSE GENERATOR (IPG) AND SCALPS LEAD EXTENSION INCISION SITES FROM A RECENT REVISION. THIS EVENT WAS PREVIOUSLY REPORTED. SEE MFR. REPORT 3006630150-2024-04766. CULTURES WERE TAKEN AND RESULTS WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS. IT WAS NOTED THAT THE PROCEDURE NOR THE DEVICES CAUSED THE INFECTION HOWEVER THE CAUSE FOR INFECTION IS UNKNOWN PER THE PHYSICIANS ASSESSMENT. THE PATIENT UNDERWENT A PROCEDURE WHERE THE ENTIRE DBS SYSTEM WAS REMOVED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND DID WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED REDNESS, INFLAMMATION AND IMPAIRED HEALING AT THE IMPLANTABLE PULSE GENERATOR (IPG) AND SCALPS LEAD EXTENSION INCISION SITES FROM A RECENT REVISION. THIS EVENT WAS PREVIOUSLY REPORTED. SEE MFR. REPORT 3006630150-2024-04766. CULTURES WERE TAKEN AND RESULTS WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS. IT WAS NOTED THAT THE PROCEDURE NOR THE DEVICES CAUSED THE INFECTION HOWEVER THE CAUSE FOR INFECTION IS UNKNOWN PER THE PHYSICIANS ASSESSMENT. THE PATIENT UNDERWENT A PROCEDURE WHERE THE ENTIRE DBS SYSTEM WAS REMOVED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1981825 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 762502 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention