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

Model Number	6010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
Event or Problem Description
It was reported the patient experienced erosion at the burr hole cap.Surgical intervention took place on (b)(6) 2026 wherein the area was cleaned out and the burr hole cap was explanted and replaced to address the issue.

• Brand Name: GUARDIAN¿ CRANIAL BURR HOLE COVER SYSTEM
• Common Device Name: DBS BURR HOLE
• 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: 25394495
• Report Number: 1627487-2026-08243
• Device Sequence Number: 17441169
• Product Code: MHY
• UDI-Device Identifier: 05415067030283
• UDI-Public: (01)05415067030283(10)10770576(17)270319
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

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: 10770576
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2025
• 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 BURR HOLE.; DBS EXTENSIONS X 2.; DBS IPG.; DBS LEADS X 2.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 68 KG