MAUDE Adverse Event Report: ABBOTT MEDICAL GUARDIAN¿ CRANIAL BURR HOLE COVER SYSTEM; DBS BURR HOLE CAP

Model Number	6010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that patient experienced an infection at the lead site.As a result, surgical intervention was undertaken wherein the entire system was explanted on (b)(6) 2026 to address the issue.
Additional Manufacturer Narrative
An event of infection was reported to abbott.It was conveyed that the infection originates at the lead site(s).The entire system was explanted; however, no explanted products were returned for analysis.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.

• Brand Name: GUARDIAN¿ CRANIAL BURR HOLE COVER SYSTEM
• Common Device Name: DBS BURR HOLE CAP
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 24867122
• Report Number: 1627487-2026-01782
• Device Sequence Number: 13385346
• Product Code: MHY
• UDI-Device Identifier: 05415067030283
• UDI-Public: (01)05415067030283(10)11172675(17)271209
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 04/29/2026

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: Health Professional
• Device Model Number: 6010
• Device Catalogue Number: 6010
• Device Lot Number: 11172675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DBS EXTENSION; DBS EXTENSION; DBS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 79 KG