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

Model Number	DB-1432
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional pro code selection that applies to the indication of this device - nhl.Device analysis performed on the returned implantable pulse generator (ipg) revealed communication could not be established with a known good remote control or clinician programmer.The data logs could not be retrieved or analyzed, and no functional testing could be performed.This damage is typically caused by the ipgs exposure to external high voltage or high current transient sources.A labeling review was performed.This review determined the following medical therapies or procedures may turn stimulation off or may cause permanent damage to the stimulator, particularly if used in close proximity to the device, this includes lithotripsy, electrocautery, external defibrillation, radiation therapy, ultrasonic scanning, and high output ultrasound and may require explantation as a result of damage to the device.Additionally, labeling states x-ray and ct scans may damage the stimulator if stimulation is on.It was confirmed through objective evidence that this ipg was electively explanted due to normal end-of-life (eol).There were no device issues prior to the eol and explant procedure.It was also confirmed from the field that the device was exposed to a computed tomography (ct) scan, and x-ray imaging before the device explantation; there were no device issues or device deficiencies following these imaging procedures.Technicians have confirmed through technical analysis of the ipg that communication could not be established with a known good rc or cp.The investigation confirmed that the asic chip was damaged.This type of damage is typically caused when the ipg is exposed to high voltage transients, high current sources, and high radio frequency (rf) energy.Per the physicians implant manual, labeling states x-ray and ct scans may damage the stimulator if stimulation is on.Therefore, based on objective evidence from the field and testing of the returned device, engineers concluded that the ipg was likely damaged unintentionally.
Event or Problem Description
Device analysis performed on the returned implantable pulse generator (ipg) revealed communication could not be established with a known good remote control or clinician programmer.Investigation of the internal electrical measurements revealed excessive sleep current and low resistance of a node where high resistance was expected, which confirms that the application-specific integrated circuit (asic) chip is damaged.

• 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 ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21612573
• Report Number: 3006630150-2025-01547
• Device Sequence Number: 12678219
• Product Code: MHY
• UDI-Device Identifier: 08714729985037
• UDI-Public: 08714729985037
• 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: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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: 08/05/2022
• Device Model Number: DB-1432
• Device Catalogue Number: DB-1432
• Device Lot Number: 200878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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 Sex: Unknown