MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	DB-2201-45DC
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Shaking/Tremors (2515); Insufficient Information (4580)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional pro code selection that applies to the indication of this device .
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure due to inadequate stimulation and elective replacement for system upgrade as a directional lead implanted to improve benefits.The patient is doing great post operatively with no complications, waiting for new lead to be programmed.The explanted device will not be returned as it was disposed per facility policy.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure due to inadequate stimulation and elective replacement for system upgrade as a directional lead implanted to improve benefits.The patient is doing great post operatively with no complications, waiting for new lead to be programmed.The explanted device will not be returned as it was disposed per facility policy.
Additional Manufacturer Narrative
Supplemental submitted to include additional information that changed field h6.Block b3: approximated based on the date the manufacturer became aware of the event.Additional pro code selection that applies to the indication of this device .

• Brand Name: NA
• 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: 21900185
• Report Number: 3006630150-2025-02737
• Device Sequence Number: 11777010
• Product Code: MHY
• UDI-Device Identifier: 08714729836544
• UDI-Public: (01)08714729836544(17)210513(10)5148985
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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): 05/21/2025

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: 05/13/2021
• Device Model Number: DB-2201-45DC
• Device Catalogue Number: DB-2201-45DC
• Device Lot Number: 5148985
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 05/14/2019
• 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: 70 YR
• Patient Sex: Male