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

Model Number	DB-4600-C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Itching Sensation (1943); Perforation (2001); Impaired Healing (2378)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: additional applicable product codes: pjs, nhl.Additional suspect medical device components involved in the event: product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch: 7129068.Udi: (b)(4).
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a burr hole cover and lead explant due to infection at the burr hole cover site.The patient presented with an open wound, and the physician suspected that the patient may have been scratching the site.The patient was placed on antibiotics.Although cultures were obtained, the results were not disclosed.The patient was reported to be doing well postoperatively.The explanted devices will not be returned to boston scientific, as they were retained by the facility.
Event or Problem Description
It was reported that the deep brain stimulation (dbs) patient underwent a burr hole cover and lead explant due to infection at the burr hole cover site.The patient presented with an open wound, and the physician suspected that the patient may have been scratching the site.The patient was placed on antibiotics.Although cultures were obtained, the results were not disclosed.The patient was reported to be doing well postoperatively.The explanted devices will not be returned to boston scientific, as they were retained by the facility.
Additional Manufacturer Narrative
Correction to block h6.Block d2b: additional applicable product codes: pjs, nhl.Additional suspect medical device components involved in the event: product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch: 7129068.Udi: (b)(4).

• Brand Name: SURETEK?
• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22865907
• Report Number: 3006630150-2025-06722
• Device Sequence Number: 7650755
• Product Code: MHY
• UDI-Device Identifier: 08714729820802
• UDI-Public: (01)08714729820802(17)260822(10)34665054
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: 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): 11/21/2025

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: 08/22/2026
• Device Model Number: DB-4600-C
• Device Catalogue Number: DB-4600-C
• Device Lot Number: 34665054
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 11/21/2025
• Date Device Manufactured: 08/22/2024
• 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: 51 YR
• Patient Sex: Female