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

Model Number	DB-1232
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Atrial Fibrillation (1729); Pneumonia (2011); Sepsis (2067); Shaking/Tremors (2515); Convulsion/Seizure (4406); Ischemia Stroke (4418); Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient experienced a possible wound infection.The patient underwent a revision procedure where the wound was sutured over.The patient was being treated for a urinary tract infection (uti) at the time.The patient was discharged home.The patient then returned to the hospital a week later with altered mental status.Later in the week the patent went into afib and began to seize.The patient underwent an explant procedure where the full dbs system was removed, and a culture was taken and everything was negative; no signs of infection were found.The patient did have pneumonia, and other cardiac morbidities and was found to have had a stroke.The physician assessed that the patient has multiple comorbidities and is systemically ill.He assessed that the uti, altered mental status, pneumonia, sepsis, afib and cardiac issues were not related to the device or device stimulation.The physician assessed that the patients uncontrolled afib lead to the stroke, the stroke (rolandic fissure stroke) was in a region of the brain that is known to cause seizures, the patient remains in the hospital, and tremors have returned as the dbs system was removed.The patient was administered antibiotics prophylactically.The explanted devices were retained by the medical facility and were not returned.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model: db-2203-45 serial: (b)(6) batch: 5005866 catalog description: argyle lead 45cm sterile kit udi: (b)(4) model: db-2203-45 serial: (b)(6) batch: 5006578 catalog description: argyle lead 45cm sterile kit udi: (b)(4) model: db-3216-55 serial: (b)(6) batch: 5005393 catalog description: argyle extension 55cm sterile kit udi: (b)(4) model: db-3216-55 serial: (b)(6) batch: 5005471 catalog description: argyle extension 55cm sterile kit udi: (b)(4) model: db-4600-c serial: na batch: 38685836 catalog description: suretek burr hole cover kit udi: (b)(6) model: db-4600-c serial: na batch: 36907766 catalog description: suretek burr hole cover kit udi: (b)(4).

• 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: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50260541
• Report Number: 3006630150-2026-05919
• Device Sequence Number: 15986347
• Product Code: PJS
• UDI-Device Identifier: 08714729985051
• UDI-Public: (01)08714729985051(17)271112(10)811027
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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 Model Number: DB-1232
• Device Catalogue Number: DB-1232
• Device Lot Number: 811027
• 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: 07/20/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 11/12/2025
• 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: 76 YR
• Patient Sex: Female