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	Nonstandard Device (1420)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Pressure Sore/Ulcer (2326)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporters phone number is (b)(6) reported here as phone number exceeded character limit for designated field.Additional suspect medical device components involved in the event: model: db-2202-45 serial: (b)(6).Batch: 7136519 catalog description: dbs directional lead sterile kit 45cm udi: (b)(4).Model: db-4600-c serial: (b)(6).Batch: 35817612 catalog description: suretek burr hole cover kit udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient developed a decubitus ulcer and skin erosion over the burr hole cover and lead, resulting in the lead becoming visible through the skin.Purulent discharge was noted at the erosion site, raising concern for infection.The patient was started on antibiotics and subsequently underwent surgical debridement and a revision procedure.During the procedure, the leads were partially cut proximally as far as possible, and the distal portions were removed.The remaining proximal segments of the leads were left in place and remained connected to the extensions.The burr hole cover was also explanted.Postoperatively, the patient recovered well.The partially explanted lead segments and burr hole cover were disposed of by the facility and were not returned.
Additional Manufacturer Narrative
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.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 product labeling found no anomalies.The labeling appropriately identifies infection, implant site complications (including poor healing and wound dehiscence), and the potential for implanted components (stimulator, lead, or lead extensions) to migrate or erode through the skin as known risks associated with deep brain stimulation (dbs).It also notes that these conditions may require additional surgical intervention.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 and skin erosion are known risks associated with the use of deep brain stimulation (dbs) as documented in the instructions for use (ifu).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient developed a decubitus ulcer and skin erosion over the burr hole cover and lead, resulting in the lead becoming visible through the skin.Purulent discharge was noted at the erosion site, raising concern for infection.The patient was started on antibiotics and subsequently underwent surgical debridement and a revision procedure.During the procedure, the leads were partially cut proximally as far as possible, and the distal portions were removed.The remaining proximal segments of the leads were left in place and remained connected to the extensions.The burr hole cover was also explanted.Postoperatively, the patient recovered well.The partially explanted lead segments and burr hole cover were disposed of by the facility and were not returned.Additional information was received indicating a culture was taken and was positive for serratia marcescens.The physician noted that the wound healing disorder was related to the device due to possible pressure ulcer, but the infection was not.Additional information was received indicating the presence of another pressure ulcer that was observed behind the ear along the lead extension with the presence of the same serratia marcescens infection.The patient underwent a revision procedure where the remaining dbs devices were explanted.The patient was doing well postoperatively.The remaining explanted devices were disposed by the facility and were not returned.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient developed a decubitus ulcer and skin erosion over the burr hole cover and lead, resulting in the lead becoming visible through the skin.Purulent discharge was noted at the erosion site, raising concern for infection.The patient was started on antibiotics and subsequently underwent surgical debridement and a revision procedure.During the procedure, the leads were partially cut proximally as far as possible, and the distal portions were removed.The remaining proximal segments of the leads were left in place and remained connected to the extensions.The burr hole cover was also explanted.Postoperatively, the patient recovered well.The partially explanted lead segments and burr hole cover were disposed of by the facility and were not returned.Additional information was received indicating a culture was taken and was positive for serratia marcescens.The physician noted that the wound healing disorder was related to the device due to possible pressure ulcer, but the infection was not.Additional information was received indicating the presence of another pressure ulcer that was observed behind the ear along the lead extension with the presence of the same serratia marcescens infection.The patient underwent a revision procedure where the remaining dbs devices were explanted.The patient was doing well postoperatively.The remaining explanted devices were disposed by the facility and were not returned.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model: db-3128-55.Serial: (b)(6).Batch: 5004518.Catalog description: dbs 2x8 extension 55cm sterile kit.Udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient developed a decubitus ulcer and skin erosion over the burr hole cover and lead, resulting in the lead becoming visible through the skin.Purulent discharge was noted at the erosion site, raising concern for infection.The patient was started on antibiotics and subsequently underwent surgical debridement and a revision procedure.During the procedure, the leads were partially cut proximally as far as possible, and the distal portions were removed.The remaining proximal segments of the leads were left in place and remained connected to the extensions.The burr hole cover was also explanted.Postoperatively, the patient recovered well.The partially explanted lead segments and burr hole cover were disposed of by the facility and were not returned.Additional information was received indicating a culture was taken and was positive for serratia marcescens.The physician noted that the wound healing disorder was related to the device due to possible pressure ulcer, but the infection was not.Additional information was received indicating the presence of another pressure ulcer that was observed behind the ear along the lead extension with the presence of the same serratia marcescens infection.The patient underwent a revision procedure where the remaining dbs devices were explanted.The patient was doing well postoperatively.The remaining explanted devices were disposed by the facility and were not returned.
Additional Manufacturer Narrative
Correction to field h6 evaluation conclusion codes and h11 additional mfr narrative - device evaluation analysis.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.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 product labeling found no anomalies.The labeling appropriately identifies infection, implant site complications (including poor healing and wound dehiscence), and the potential for implanted components (stimulator, lead, or lead extensions) to migrate or erode through the skin as known risks associated with deep brain stimulation (dbs).It also notes that these conditions may require additional surgical intervention.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.Therefore, the root cause of the reported clinical observations cannot be established.

• 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: 24613100
• Report Number: 3006630150-2026-01534
• Device Sequence Number: 18602318
• Product Code: NHL
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/04/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7089304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 04/13/2026; 05/11/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/13/2026; 05/08/2026; 06/04/2026
• Date Device Manufactured: 06/16/2025
• 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: Male