BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA?

    MDR report key: 24464556 · Received February 26, 2026

    Report

    Report Number
    3006630150-2026-01134
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    February 24, 2026
    Report Date
    May 1, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE RETAINED BY THE FACILITY AND NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AND STATES THAT LOSS OF ADEQUATE STIMULATION, IMPLANTED DEVICE COMPONENTS (STIMULATOR, LEAD, OR LEAD EXTENSION) MAY MOVE FROM ORIGINAL IMPLANTED LOCATION OR WEAR THROUGH THE SKIN, WHICH MAY LEAD TO THE NEED FOR ADDITIONAL SURGERY, AND WEAKNESS, MUSCLE SPASMS, SHAKING, RESTLESSNESS, OR PROBLEMS WITH MOVEMENT ARE A KNOWN RISKS WITH THE USE OF DEEP BRAIN STIMULATION. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODE: NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6). BATCH: 7133494 UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODE: NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 7133494 UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODE: NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7133494, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A LEAD REPLACEMENT DUE TO SUBOPTIMAL PLACEMENT. THE LEADS HAD NOT BEEN PLACED IN THE SUBTHALAMIC NUCLEUS (STN), AND THEREFORE THE PATIENT WAS UNABLE TO RECEIVE THERAPY. AS A CONSEQUENCE OF THE SUBOPTIMAL PLACEMENT, THE PATIENT EXPERIENCED STIFFNESS AND TREMOR. THE PATIENT'S POSTOPERATIVE STATUS IS GOOD, WITH FULL RECOVERY EXPECTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED, AS THEY WERE RETAINED BY THE FACILITY. ADDITIONAL INFORMATION RECEIVED STATED THAT, FOLLOWING THE LEADS EXPLANT, THE PATIENT UNDERWENT AN ELECTIVE REVISION PROCEDURE IN ORDER TO CONNECT THE NEW LEADS. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS, AS THEY WERE RETAINED BY THE FACILITY. THE PATIENT'S POSTOPERATIVE STATUS WAS GOOD AND FOLLOWED NORMAL PROCEDURE AND PROTOCOL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A LEAD REPLACEMENT DUE TO SUBOPTIMAL PLACEMENT. THE LEADS HAD NOT BEEN PLACED IN THE SUBTHALAMIC NUCLEUS (STN), AND THEREFORE THE PATIENT WAS UNABLE TO RECEIVE THERAPY. AS A CONSEQUENCE OF THE SUBOPTIMAL PLACEMENT, THE PATIENT EXPERIENCED STIFFNESS AND TREMOR. THE PATIENT'S POSTOPERATIVE STATUS IS GOOD, WITH FULL RECOVERY EXPECTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED, AS THEY WERE RETAINED BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A LEAD REPLACEMENT DUE TO SUBOPTIMAL PLACEMENT. THE LEADS HAD NOT BEEN PLACED IN THE SUBTHALAMIC NUCLEUS (STN), AND THEREFORE THE PATIENT WAS UNABLE TO RECEIVE THERAPY. AS A CONSEQUENCE OF THE SUBOPTIMAL PLACEMENT, THE PATIENT EXPERIENCED STIFFNESS AND TREMOR. THE PATIENT'S POSTOPERATIVE STATUS IS GOOD, WITH FULL RECOVERY EXPECTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED, AS THEY WERE RETAINED BY THE FACILITY. ADDITIONAL INFORMATION RECEIVED STATED THAT, FOLLOWING THE LEADS EXPLANT, THE PATIENT UNDERWENT AN ELECTIVE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD EXTENSIONS REVISION IN ORDER TO CONNECT THE NEW LEADS. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS, AS THEY WERE RETAINED BY THE FACILITY. THE PATIENT'S POSTOPERATIVE STATUS WAS GOOD AND FOLLOWED NORMAL PROCEDURE AND PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211426 VERCISE? CARTESIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7133441 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1