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

Model Number	DB-2201-45DC
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient treated for epilepsy, developed an infection at the lead/lead-extension connection incision behind the right ear.The patient's symptoms included pus and oozing at the incision site.The patient was placed on antibiotics.Cultures were taken, and methicillin-resistant staphylococcus aureus (mrsa) was confirmed.The patient is currently doing well, with no additional hospitalization or treatment required at this time.The devices will not be returned to boston scientific for analysis, as they remain implanted in the patient.
Additional Manufacturer Narrative
Block d2b: additional applicable product codes: pjs, nhl.Additional suspect medical device components involved in the event: product family: dbs-extension upn: m365db312855b0, model: db-3128-55b, serial: (b)(6), batch: (b)(6), udi: (b)(4).Product family: dbs-extension upn: m365db312855b0, model: db-3128-55b, serial: (b)(6), batch: (b)(6), udi: (b)(4).Product family: dbs-linear leads upn: m365db220145dc0, model: db-2201-45dc, serial: (b)(6), batch: 7075043, udi: (b)(4).Product family: dbs-linear leads upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: (b)(6), udi: (b)(4).Product family: dbs-linear leads upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: (b)(6), udi: (b)(4).
Additional Manufacturer Narrative
Block d2b: additional applicable product codes: pjs, nhl.Additional suspect medical device components involved in the event: product family: dbs-extension.Upn: m365db312855b0.Model: db-3128-55b.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).Product family: dbs-extension.Upn: m365db312855b0.Model: db-3128-55b.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).Product family: dbs-linear leads.Upn: m365db220145dc0.Model: db-2201-45dc.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).Product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).Product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch: (b)(6).Udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient treated for epilepsy, developed an infection at the lead/lead-extension connection incision behind the right ear.The patient's symptoms included pus and oozing at the incision site.The patient was placed on antibiotics.Cultures were taken, and methicillin-resistant staphylococcus aureus (mrsa) was confirmed.The patient is currently doing well, with no additional hospitalization or treatment required at this time.The devices will not be returned to boston scientific for analysis, as they remain implanted in the patient.

• Brand Name: NA
• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23812182
• Report Number: 3006630150-2025-11452
• Device Sequence Number: 12667866
• Product Code: MHY
• UDI-Device Identifier: 08714729836544
• UDI-Public: (01)08714729836544(17)260306(10)7075038
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 03/06/2026
• Device Model Number: DB-2201-45DC
• Device Catalogue Number: DB-2201-45DC
• Device Lot Number: 7075038
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 12/19/2025
• Date Device Manufactured: 03/06/2024
• 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 Age: 17 YR
• Patient Sex: Female
• Patient Race: White