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

Model Number	DB-1110-C
Medical Device Problem Codes	Charging Problem (2892); Wireless Communication Problem (3283); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced difficulty charging and communicating with their implantable pulse generator (ipg).Radiographic imaging revealed that the ipg had rotated from its original position, was situated unusually low in the chest, and exhibited excessive mobility.The physician determined that ipg migration was the likely cause of the patients charging and communication issues.Consequently, the patient underwent an ipg revision procedure.The ipg was retained by the medical facility and will not be returned for analysis.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced difficulty charging and communicating with their implantable pulse generator (ipg).Radiographic imaging revealed that the ipg had rotated from its original position, was situated unusually low in the chest, and exhibited excessive mobility.The physician determined that ipg migration was the likely cause of the patient's charging and communication issues.Consequently, the patient underwent an ipg revision procedure.The ipg was retained by the medical facility and will not be returned for analysis.Additional information was received that the patient is doing well postoperatively.

• Brand Name: VERCISE?
• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22556283
• Report Number: 3006630150-2025-05704
• Device Sequence Number: 9566650
• Product Code: NHL
• UDI-Device Identifier: 08714729820758
• UDI-Public: (01)08714729820758(17)180919(10)2000016855
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• 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): 08/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/19/2018
• Device Model Number: DB-1110-C
• Device Catalogue Number: DB-1110-C
• Device Lot Number: 2000016855
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/18/2025
• Date Device Manufactured: 09/19/2016
• 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
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 80 KG