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

Model Number	DB-2201-45DC
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that the patient undergoing deep brain stimulation (dbs) experienced insufficient stimulation, which adversely affected mobility in his left leg.As a result, a lead explant procedure was performed.
Event or Problem Description
It was reported that the patient undergoing deep brain stimulation (dbs) experienced insufficient stimulation, which adversely affected mobility in his left leg.As a result, a lead explant procedure was performed.Additional information was received that the patient began experiencing symptoms following her dbs programming session.Although the physician does not attribute the symptoms to the programming, the underlying cause remains unknown.A magnetic resonance imaging (mri) was performed and confirmed the absence of any additional pathologies.Consequently, the therapy has been deactivated and no further issues have been reported.The lead has been discarded and will not be returned for further analysis.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the patient undergoing deep brain stimulation (dbs) experienced insufficient stimulation, which adversely affected mobility in his left leg.As a result, a lead explant procedure was performed.Additional information was received that the patient began experiencing symptoms following her dbs programming session.Although the physician does not attribute the symptoms to the programming, the underlying cause remains unknown.A magnetic resonance imaging (mri) was performed and confirmed the absence of any additional pathologies.Consequently, the therapy has been deactivated and no further issues have been reported.The lead has been discarded and will not be returned for further analysis.

• Brand Name: NA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• 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: 22500318
• Report Number: 3006630150-2025-05475
• Device Sequence Number: 21014355
• Product Code: NHL
• UDI-Device Identifier: 08714729836544
• UDI-Public: (01)08714729836544(17)241206(10)7073368
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 10/22/2025

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: 12/06/2024
• Device Model Number: DB-2201-45DC
• Device Catalogue Number: DB-2201-45DC
• Device Lot Number: 7073368
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 07/19/2025; 09/29/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/13/2025; 10/22/2025
• Date Device Manufactured: 12/07/2022
• 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