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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional pro code selection that applies to the indication of this device - nhl.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient enrolled in clinical study (b)(6) developed bilateral dehiscence wounds at the site of the implantable pulse generator (ipg).The wounds were cleaned, and medication was administered.The event was resolving.This non serious adverse event was reported as related to the procedure and not related to the hardware or stimulation.
Additional Manufacturer Narrative
Additional pro code selection that applies to the indication of this device - nhl.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient enrolled in clinical study a4010 developed bilateral dehiscence wounds at the site of the implantable pulse generator (ipg).The wounds were cleaned, and medication was administered.The event was resolving.This non serious adverse event was reported as related to the procedure and not related to the hardware or stimulation.Additional information was received indicating the wound dehiscence was located at the site of the lead not the ipg.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient enrolled in clinical study a4010 developed bilateral dehiscence wounds at the site of the implantable pulse generator (ipg).The wounds were cleaned, and medication was administered.The event was resolving.This non serious adverse event was reported as related to the procedure and not related to the hardware or stimulation.Additional information was received indicating the wound dehiscence was located at the site of the lead not the ipg.Additional information was received providing the model and serial number of the lead.
Additional Manufacturer Narrative
Additional pro code selection that applies to the indication of this device - nhl.

• 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: 20588996
• Report Number: 3006630150-2024-07478
• Device Sequence Number: 8796945
• Product Code: MHY
• UDI-Device Identifier: 08714729905271
• UDI-Public: 08714729905271
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2025

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 Expiration Date: 05/14/2026
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7085558
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 11/25/2024; 01/15/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/18/2024; 01/28/2025
• Date Device Manufactured: 05/14/2024
• 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