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

Model Number	DB-1416
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Use of Device Problem (1670); Device Displays Incorrect Message (2591); Wireless Communication Problem (3283)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a non-boston scientific related procedure to implant a pacemaker the deep brain stimulation (dbs) implantable pulse generator (ipg) was damaged.It was indicated that the stimulation was not properly turned off before the procedure as they thought it had been.After the procedure was completed the ipg was unable to enter into pairing mode in order to turn the stimulation back on resulting in a return of tremors in the upper extremities.Attempts were made to establish a connection between the remote control (rc) and ipg but continued to receive communication error messages.Attempts were made to evaluate the ipg but were unsuccessful as communication could not be established between the clinician programmer (cp) and ipg.It was indicated that before the procedure began the sales representative misread the type of ipg model the patient was implanted with and suggested using a magnet to turn the device stimulation off to expedite the process and not cause any delays with the procedure.Upon doing so in pre-op the patient was asked if he felt the device stimulation turn off and he said yes and also exhibited tremor symptoms which led to the belief that the device had indeed been turned off.Upon further investigation post procedure, the sales representative realized the gravity of the mistake of using the magnet to try and turn the stimulator off.It was confirmed that the stimulation being on during the procedure and the use of bipolar cautery most likely damaged the ipg.The patient underwent a revision procedure where the ipg was replaced.The patient was doing well postoperatively but was experiencing soreness and a bit of fogginess.

• Brand Name: Vercise Genus?
• 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; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50857148
• Report Number: 3006630150-2026-06992
• Device Sequence Number: 10026484
• Product Code: PJS
• UDI-Device Identifier: 08714729985020
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/08/2026
• Device Model Number: DB-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 226545
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 03/08/2024
• 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: Male