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

Model Number	DB-2201-45DC
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Shaking/Tremors (2515); Movement Disorder (4412)
Date of Event	12/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a return of their parkinson's disease symptoms, tremors, on the left side of the body, no trauma was reported.Due to a lack of therapy from their deep brain stimulation (dbs) system.During reprogramming high impedances were noted on the leads, therapy was able to address the patients' symptoms but not as well as prior to identifying the impedances.It was also stated that the patient lost therapy, and that it was taking longer to charge the implantable pulse generator (ipg).Computerized tomography scan (ct scan) was performed and confirmed that the right lead retracted cephalad to the subthalamic nucleus (stn) by approximately two inches which was confirmed as the reason for the patient having lost therapy on their left side.The patient underwent a procedure in which the system was explanted.Device analysis cannot be conducted as the devices were not returned.
Additional Manufacturer Narrative
Block d2b pro code (product code): nhl, pjs additional suspect medical device components involved in the event: model number/catalog number: db-2201-45dc serial number: (b)(6).Batch/lot number: 21239846 model/catalog description: lead kit 45cm unique identifier (udi) # (b)(4).Model number/catalog number: db-1110c serial number: (b)(6).Batch/lot number 21606574 model/catalog description: vercise ipg unique identifier (udi) # (b)(4).Model number/catalog number: nm-3138-55 serial number: (b)(6).Batch/lot number: 7003812 model/catalog description: 55cm 8 contact extension unique identifier (udi) # (b)(4).Model number/catalog number: nm-3138-55 serial number: (b)(6).Batch/lot number: 7004051 model/catalog description: 7004051 unique identifier (udi) # (b)(4).
Additional Manufacturer Narrative
Block d2b pro code (product code): nhl, pjs.
Event or Problem Description
It was reported that the patient experienced a return of their parkinson's disease symptoms, tremors, on the left side of the body, no trauma was reported.Due to a lack of therapy from their deep brain stimulation (dbs) system.During reprogramming high impedances were noted on the leads, therapy was able to address the patients' symptoms but not as well as prior to identifying the impedances.It was also stated that the patient lost therapy, and that it was taking longer to charge the implantable pulse generator (ipg).Computerized tomography scan (ct scan) was performed and confirmed that the right lead retracted cephalad to the subthalamic nucleus (stn) by approximately two inches which was confirmed as the reason for the patient having lost therapy on their left side.The patient underwent a procedure in which the system was explanted.Device analysis cannot be conducted as the devices were not returned.

• 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: 23572172
• Report Number: 3006630150-2025-10485
• Device Sequence Number: 13294196
• Product Code: MHY
• UDI-Device Identifier: 08714729836544
• UDI-Public: (01)08714729836544(17)200205(10)680196
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2020
• Device Model Number: DB-2201-45DC
• Device Catalogue Number: DB-2201-45DC
• Device Lot Number: 680196
• 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: 05/24/2021
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 11/18/2025
• Date Device Manufactured: 02/05/2018
• 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 Age: 52 YR
• Patient Sex: Male