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

Model Number	DB-2202-30
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Communication or Transmission Problem (2896); Migration (4003)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced lead migration of the left brain lead wherein it was no longer at target position.The patient was experiencing difficulty walking, running and a progression of dystonia symptoms.The patient underwent a revision procedure where the left-brain lead was replaced.The physician decided to replace the right brain lead as well to achieve better therapeutic results.During the procedure monopolar electrocautery was performed.Communication between the remote control and the implantable pulse generator (ipg) failed.After multiple attempts to communicate with the ipg, the surgeon decided to replace the ipg due to suspected damage from electrocautery.The patient was doing well post-operatively.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202300, model: db-2202-30, serial: (b)(6), batch: 7080434.Product family: dbs-ipg-r-mri, upn: m365db12160, model: db-1216, serial: (b)(6), batch: 561379.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced lead migration of the left brain lead wherein it was no longer at target position.The patient was experiencing difficulty walking, running and a progression of dystonia symptoms.The patient underwent a revision procedure where the left-brain lead was replaced.The physician decided to replace the right brain lead as well to achieve better therapeutic results.During the procedure monopolar electrocautery was performed.Communication between the remote control and the implantable pulse generator (ipg) failed.After multiple attempts to communicate with the ipg, the surgeon decided to replace the ipg due to suspected damage from electrocautery.The patient was doing well post-operatively.
Additional Manufacturer Narrative
The returned ipg db-1216 serial number (b)(6) revealed communication could not be established with a known good remote control or clinician programmer.Therefore, the data logs could not be retrieved or analyzed, and no functional testing could be performed.The ipg was then cut open, and internal electrical measurements revealed excessive sleep current and low resistance of a node where high resistance was expected, which confirms that the application-specific integrated circuit asic chip is damaged.This damage is typically caused by the ipg exposure to electrocautery.A product labeling review was conducted.This review determined that the procedure of electrocautery may turn stimulation off or may cause permanent damage to the stimulator.If this type of procedure is required by medical necessity, the procedure should be performed as far from the implanted components as possible.The returned lead db-2202-30 serial number (b)(6) was analyzed and visual inspection revealed that the lead was cleanly cut into two pieces approximately 11 cm from the proximal end of the lead and the distal portion of the lead was not returned.The clean-cut damage is a result of a typical explant procedure, and it is not considered a failure.Electrical test could not be performed due the cut lead body.No other anomalies were identified on the returned portion of the lead.A labeling review was conducted.This review determined that loss of adequate stimulation, gait difficulty, trouble walking, falls and weakness, muscle spasms, shaking, restlessness, or problems with movement are a known risk with the use of deep brain stimulation.The lead db-2202-30 serial number 7080471 was not returned for analysis.Therefore, analysis could not be completed in our laboratory.

• 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: 19415634
• Report Number: 3006630150-2024-03450
• Device Sequence Number: 20974277
• Product Code: NHL
• UDI-Device Identifier: 08714729905271
• UDI-Public: 08714729905271
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: 04/01/2025
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7080471
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2023
• 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 Age: 12 YR
• Patient Sex: Female