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

Model Number	DB-2201-45DC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); Itching Sensation (1943)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed an infection, with signs of itching and an open wound, at the lead site of the deep brain stimulation (dbs) system and underwent a revision procedure in which the lead extension was explanted and discarded.The patient is doing well post operatively; the infection has resolved and is undergoing medical treatment.The specific details of the revision procedure are unknown; however, it was stated that the therapy was turned off during the explant procedure, and the patient and family have requested additional assistance obtaining additional therapy.Detailed product information was not provided to bsc for the lead extension, despite having completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Block d2b pro code (product code): nhl.Additional suspect medical device components involved in the event: model number/catalog number: db-2201-45dc, serial number: (b)(6), batch/lot number: 7070900, model/catalog description: lead kit 45cm, unique identifier (udi) # (b)(4).Model number/catalog number: dbs-extension.

• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50942106
• Report Number: 3006630150-2026-07212
• Device Sequence Number: 21517616
• Product Code: MHY
• UDI-Device Identifier: 08714729836544
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/11/2022
• Device Model Number: DB-2201-45DC
• Device Catalogue Number: DB-2201-45DC
• Device Lot Number: 7070896
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 08/11/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown