BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA?

    MDR report key: 24405096 · Received February 20, 2026

    Report

    Report Number
    3006630150-2026-01034
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    December 9, 2025
    Report Date
    April 7, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7131310, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7131266, UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 7083688, UDI: (B)(4). PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(6), BATCH: 775904, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    PHYSICAL ANALYSIS COULD NOT BE COMPLETED IN OUR LABORATORY, AS THE DEVICES WERE DISPOSED OF BY THE MEDICAL FACILITY AND WERE NOT RETURNED. A REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED WITH THESE DEVICES INDICATED THAT THEY WERE SUCCESSFULLY PROCESSED ACCORDING TO REQUIREMENTS. THE DHR DID NOT IDENTIFY ANY MANUFACTURING PROCESS-RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING PRODUCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE DHR REVIEW ENSURES EACH DEVICE MEETS REQUIRED SPECIFICATIONS AND ASSOCIATED TESTING PRIOR TO RELEASE FOR DISTRIBUTION/SALE. A LABELLING REVIEW WAS PERFORMED BASED ON THE DFU AND IT DID NOT REVEAL ANY ANOMALIES AS IT STATES THAT INFECTION IS A KNOWN RISK WITH THE USE OF DEEP BRAIN STIMULATION (DBS). THE DEVICES WERE NOT RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY. AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. HOWEVER, A LABELING REVIEW WAS CONDUCTED. THIS REVIEW DETERMINED THE REPORTED EVENT OF INFECTION IS A KNOWN RISK ASSOCIATED WITH THE USE OF DEEP BRAIN STIMULATION (DBS) AS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION NEAR THE TUNNELING SITE BY THE RIGHT EAR RESULTING IN FLUID DISCHARGE. A CULTURE WAS TAKEN AND CONFIRMED A PSEUDOMONAS INFECTION. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION NEAR THE TUNNELING SITE BY THE RIGHT EAR RESULTING IN FLUID DISCHARGE. A CULTURE WAS TAKEN AND CONFIRMED A PSEUDOMONAS INFECTION. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466879 VERCISE? CARTESIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7123941 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention