BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE DBS

    MDR report key: 19539050 · Received June 14, 2024

    Report

    Report Number
    3006630150-2024-03857
    Event Type
    Injury
    Date Received
    June 14, 2024
    Date of Event
    May 21, 2024
    Report Date
    October 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI. UPN: M365DB12160. MODEL: DB-1216. SERIAL: (B)(6). BATCH: 567030. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7123047.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION OF THE LEAD EXTENSION WHEREIN IT WAS VISIBLE THROUGH THE SKIN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSION WAS EXPLANTED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED DEVICE WAS RETAINED BY THE FACILITY AND WAS NOT RETURNED TO BSC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION OF THE LEAD EXTENSION WHEREIN IT WAS VISIBLE THROUGH THE SKIN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSION WAS EXPLANTED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED DEVICE WAS RETAINED BY THE FACILITY AND WAS NOT RETURNED TO BSC. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS AN INFECTION AT THE SITE OF THE IMPLANTABLE PULSE GENERATOR (IPG) IN ADDITION TO THE EROSION ORIGINALLY REPORTED IN (MFR 3006630150-2024-03857) WHEREIN THE IPG AND AN ADDITIONAL LEAD EXTENSION WERE EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE EXPLANTED DEVICES WERE RETAINED BY THE FACILITY AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389965 VERCISE DBS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION NM-3138-55 7123141 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention