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

Model Number	DB-2202-30
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that high impedances were noted on the deep brain stimulation lead.The patient underwent a procedure where the lead was replaced.The patient is expected to fully recover.
Additional Manufacturer Narrative
Visual and x-ray inspection of the lead revealed that this lead was bent/kinked 9 cm from the distal end and multiple cables were fractured at this location.The fractured cables resulted in the reported high impedances.Laboratory analysis determined that the kinked section of the lead body is where it was secured in the base of the burr hole cover (bhc) and appears that the lead body was kinked after it was placed on the exit slot of the bhc base.
Event or Problem Description
It was reported that high impedances were noted on the deep brain stimulation lead.The patient underwent a procedure where the lead was replaced.The patient is expected to fully recover.

• Brand Name: VERCISE CARTESIA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 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: 17795395
• Report Number: 3006630150-2023-05746
• Device Sequence Number: 19380444
• 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: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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 Expiration Date: 05/13/2020
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 5027170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2018
• 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