MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Vercise? Cartesia?; stimulator, electrical, implanted, for parkinsonian tremor

Model Number	DB-2202-45
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); Convulsion/Seizure (4406)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an office follow up visit it was noted that the patient who is implanted with the deep brain stimulation (dbs) leads developed a needle sized dehiscence on the left side but appeared well.While at home the patient experienced convulsions and was hospitalized, computerized tomography scan (ct) imaging was performed, and a strange shape was seen in the results.The patient underwent a revision procedure.It was stated that nothing of note occurred during the procedure that may have contributed to the patient's condition, however, it was noted that the patient has thin skin.During the revision procedure the left lead and left burr hole cover were explanted, however it is unknown which of the two implanted leads or burr hole covers was explanted.Infection was confirmed on the left side, and the patient was prescribed antibiotics.The patient is doing well post operatively, and therapy has been restarted.The devices were retained by the facility.
Additional Manufacturer Narrative
Block d2b pro code (product code): nhl additional suspect medical device components involved in the event: model number/catalog number: db-2202-45.Serial number: (b)(6).Batch/lot number: 7138671.Model/catalog description: dbs directional lead sterile kit 45cm.Unique identifier (udi) # (b)(4).Model number/catalog number: db-4600-c.Serial number: n/a.Batch/lot number: 38666947 and 38639103.Model/catalog description: suretek burr hole cover kit.Unique identifier (udi) # (b)(4) and (b)(4).

• Brand Name: Vercise? Cartesia?
• Common Device Name: stimulator, electrical, implanted, for parkinsonian tremor
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; +1(763)292-0920
• MDR Report Key: 50291907
• Report Number: 3006630150-2026-05994
• Device Sequence Number: 10727111
• Product Code: MHY
• UDI-Device Identifier: 08714729905288
• UDI-Public: (01)08714729905288(17)280219(10)7149548
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7149548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 02/19/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown