BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 20088083 · Received August 28, 2024

    Report

    Report Number
    3006630150-2024-05688
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    August 8, 2024
    Report Date
    November 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS. UPN: M365DB9218150. MODEL: DB-9218-15. SERIAL: (B)(6). BATCH: 5173274. PRODUCT FAMILY: DBS-ADAPTERS. UPN: M365DB9218150. MODEL: DB-9218-15. SERIAL: (B)(6). BATCH: 7058093. ANALYSIS OF THE RETURNED IPG MODEL DB-1200-S (743028) REVEALED NORMAL DEVICE CHARACTERISTICS DURING THE VISUAL EXAMINATION. THE IPG COULD CONNECT TO A KNOWN GOOD REMOTE CONTROL (RC) WITHOUT ANY ISSUES. THE FUNCTIONAL TEST AND THE INTERNAL ELECTRICAL MEASUREMENTS CONFIRMED THAT ALL MEASUREMENTS WERE WITHIN THE EXPECTED RANGE AND THERE WAS NO EVIDENCE OF ANY ANOMALIES RELATED TO CHARGING OR BATTERY DEPLETION. THE RETURNED ADAPTERS MODEL DB-9218-15 (7058093 AND 5173274) WERE ANALYZED AND PASSED ALL TESTS PERFORMED AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE ALLEGATION OF HIGH IMPEDANCE WAS NOT CONFIRMED THEREFORE NO PROBLEM WAS DETECTED. THE ALLEGATION OF HIGH IMPEDANCE WAS NOT CONFIRMED THEREFORE NO PROBLEM WAS DETECTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS; UPN: M365DB9218150; MODEL: DB-9218-15; SERIAL: (B)(6); BATCH: 5173274. PRODUCT FAMILY: DBS-ADAPTERS; UPN: M365DB9218150; MODEL: DB-9218-15; SERIAL: (B)(6); BATCH: 7058093.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE DUE TO HIGH IMPEDANCES. THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD ADAPTERS WERE REPLACED WITH NON-BSC DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE DUE TO HIGH IMPEDANCES. THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD ADAPTERS WERE REPLACED WITH NON-BSC DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465050 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1200-S 743028 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention