BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 17208245 · Received June 27, 2023

    Report

    Report Number
    3006630150-2023-03669
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    November 17, 2020
    Report Date
    July 25, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO BLOCK H6 CONCLUSION CODE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY DBS-LINEAR LEADS, UPN M365DB2202450, MODEL DB-2202-45, SERIAL-LOT (B)(6), BATCH (B)(6). PRODUCT FAMILY DBS-EXTENSION, UPN M365NM3138550, MODEL NM-3138-55, SERIAL-LOT (B)(6), BATCH (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY DBS-LINEAR LEADS: UPN M365DB2202450. MODEL DB-2202-45. SERIAL-LOT (B)(6). BATCH 7072613 AND 7073058. PRODUCT FAMILY DBS-EXTENSION: UPN M365NM3138550. MODEL NM-3138-55. SERIAL-LOT (B)(6) BATCH 7076049 AND 7076065.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE IN WHICH THEIR ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM WAS EXPLANTED FOR AN UNKNOWN REASON. THE EXPLANTED DEVICES WILL NOT BE RETURNED. NO FURTHER INFORMATION CAN BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE IN WHICH THEIR ENTIRE DEEP BRAIN STIMULATION SYSTEM WAS EXPLANTED FOR AN UNKNOWN REASON. THE EXPLANTED DEVICES WILL NOT BE RETURNED. NO FURTHER INFORMATION CAN BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453504 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 742606 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention