MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Vercise? Cartesia?; stimulator, electrical, implanted, for parkinsonian tremor

Model Number	DB-2202-45
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure of the right sided lead of the deep brain stimulation (dbs) system, in which the lead was repositioned, during the stage 2 implant due to the lead having migrated following the stage 1 implant which was confirmed with computerized tomography scan (ct) imaging.It is unclear as to which of the two leads was repositioned.We completed a good faith effort to obtain additional information, unfortunately were unable to obtain more information.If additional details become available, a supplemental report will be submitted.No devices will be returned as they remain implanted.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: db-2202-45.Serial number: (b)(6).Batch/lot number: 7089918.Model/catalog description: dbs directional lead sterile kit 45cm.Unique identifier (udi) # (b)(4).With all the available information, boston scientific concludes that the cause of the patient experiencing lead migration of the lead and undergoing a procedure in which the lead was repositioned could not be confirmed.The devices were not returned therefore device analysis could not be done.A review of the manufacturing records associated with the device indicated that it was successfully processed according to requirements.The device history review, 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.The devices remain implanted and were not returned; therefore, a technical analysis could not be performed.A labeling review was performed on the devices' instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.It states the implanted device components (stimulator, lead, or lead extension) may move from original implanted location, which may lead to the need for additional surgery.Based on all available information, engineers are not able to confirm the root cause of the event.The devices were not returned, as such, physical analysis could not be conducted in our laboratory.Record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable root cause for the complaint, and the conclusion is cause not 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50217998
• Report Number: 3006630150-2026-05811
• Device Sequence Number: 13408673
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: (01)08714729905288(17)240307(10)7089905
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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 Expiration Date: 03/07/2024
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7089905
• 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: 06/24/2022
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 03/08/2022
• 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: 46 YR
• Patient Sex: Female