MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Vercise?; stimulator, electrical, implanted, for parkinsonian symptoms

Model Number	DB-1110-C
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Implant Pain (4561); Insufficient Information (4580)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced pain behind the ear.Upon examination, the connection between the non-boston scientific lead and the non-boston scientific extension was found to be exposed through the skin.Additionally, the patient experienced pain at the implantable pulse generator (ipg) pocket site, which was presumed to be associated with an infection, as symptoms consistent with inflammation were observed.Based on the available information, it is believed that the infection spread to the ipg through the exposed connection between the non-boston scientific lead and the non-boston scientific extension.Despite this, the patient continued to obtain therapeutic benefit from dbs therapy, and there were no allegations regarding the performance of the boston scientific devices.Due to this, the patient underwent an explant procedure of the ipg, adapters, and non-boston scientific devices.The procedure involved making an incision approximately 5 cm above the left connection site, followed by transection of the non-boston scientific lead.A separate incision was then made in the right chest, where the non-boston scientific lead component of the implanted adapter was transected.Subsequently, the ipg was explanted from the left chest together with a portion of the left-sided non-boston scientific lead and non-boston scientific extension, as well as a portion of the right-sided non-boston scientific extension, and the surgical wounds were closed in the standard manner.Following the procedure, tissue adherent to the explanted components and the explanted devices were collected and submitted for microbiological culture.Subsequently, the devices will be discarded by the hospital and will not be returned for analysis.The patient was placed on antibiotics therapy.As a consequence of the system explantation, the patient lost the therapeutic benefit of the treatment, with a recurrence of the presenting tic symptoms.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: db-9418-15.Serial number: unknown.Batch/lot number: unknown.Model/catalog description: b26 pocket adapter kit.Unique identifier (udi) #: unknown.Model number/catalog number: db-9418-15.Serial number: unknown.Batch/lot number: unknown.Model/catalog description: b26 pocket adapter kit.Unique identifier (udi) #: unknown.

• 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 ; +1(763)292-0920
• MDR Report Key: 50101985
• Report Number: 3006630150-2026-05455
• Device Sequence Number: 20146845
• Product Code: NHL
• UDI-Device Identifier: 08714729820758
• UDI-Public: (01)08714729820758(17)180804(10)19550663
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2026

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: Lay User/Patient
• Device Expiration Date: 08/04/2018
• Device Model Number: DB-1110-C
• Device Catalogue Number: DB-1110-C
• Device Lot Number: 19550663
• 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: 07/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/21/2026
• Date Device Manufactured: 08/04/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female