MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	DB-2202-30
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: additional pro codes nhl, pjs.
Event or Problem Description
It was reported that during stage one of the deep brain stimulation (dbs) implant, a low impedance was noted on the lead during functional testing.Attempts to resolve the low impedance were attempted, however were unsuccessful.The physician opted to keep the lead implanted and completed the procedure.The patient underwent the scheduled stage two of the dbs procedure four days later where the lead was removed and replaced therefore completing the scheduled and additional procedure.The patient was admitted to the hospital however was discharged several days later.The patient is doing well.
Event or Problem Description
It was reported that during stage one of the deep brain stimulation (dbs) implant, a low impedance was noted on the lead during functional testing.Attempts to resolve the low impedance were attempted, however were unsuccessful.The physician opted to keep the lead implanted and completed the procedure.The patient underwent the scheduled stage two of the dbs procedure four days later where the lead was removed and replaced therefore completing the scheduled and additional procedure.The patient was admitted to the hospital however was discharged several days later.The patient is doing well.
Additional Manufacturer Narrative
Analysis of the returned vercise cartesia lead revealed there were no shorts between contacts during electrical testing however visual inspection revealed that electrode one and the distal tip was separated from the distal end resulting with a high impedance measurement during testing.The distal tip and electrode one were not returned.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, labeling states failure or malfunction of any of the device components, including but not limited to lead or extension breakage, electrical shorts or open circuits and lead insulation breaches, whether or not this requires explant and/or reimplantation is a known inherent risk with the use of deep brain stimulation (dbs) and is documented in the instructions for use (ifu) labeling.

• 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; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21665534
• Report Number: 3006630150-2025-01701
• Device Sequence Number: 15359857
• Product Code: NHL
• UDI-Device Identifier: 08714729905271
• UDI-Public: 08714729905271
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7087409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2024
• 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: Required Intervention
• Patient Sex: Unknown