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

Model Number	DB-1110-C
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Shaking/Tremors (2515); Speech Disorder (4415)
Date of Event	04/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a lack of tremor and speech control.X-ray imaging confirmed the leads and lead extensions were appropriately placed.Troubleshooting and reprogramming efforts were unsuccessful, and eventually the implantable pulse generator (ipg) would no longer communication with the clinician programmer (cp).The patient underwent a revision procedure wherein the ipg was replaced and did well postoperatively.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a lack of tremor and speech control.X-ray imaging confirmed the leads and lead extensions were appropriately placed.Troubleshooting and reprogramming efforts were unsuccessful, and eventually the implantable pulse generator (ipg) would no longer communication with the clinician programmer (cp).The patient underwent a revision procedure wherein the ipg was replaced and did well postoperatively.
Additional Manufacturer Narrative
Analysis of the returned ipg revealed no anomalies.The ipg showed typical device characteristics throughout visual and functional testing.No communication issues were observed including testing with the cp.However, a labeling review was conducted, and revealed loss of adequate stimulation, and motor problems such as tremor, and speech or swallowing problems are known risks associated with the use of dbs system.

• Brand Name: VERCISE
• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 20355819
• Report Number: 3006630150-2024-06566
• Device Sequence Number: 12783935
• Product Code: MHY
• UDI-Device Identifier: 08714729820758
• UDI-Public: 08714729820758
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: 06/04/2017
• Device Model Number: DB-1110-C
• Device Catalogue Number: DB-1110-C
• Device Lot Number: 18033896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2015
• 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 Sex: Unknown