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

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	09/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The allegation is against 1 of 2 burr hole cover; however, it is unknown which burr hole cover, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: dbs burr hole cover, model: 6010, udi: (b)(4), serial: n/a, batch: 7684380.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
Event or Problem Description
It was reported that the patient experienced skin erosion at the right-side burr hole cover.Surgical intervention was undertaken on (b)(6) 2025 where they cleaned the area, performed a skin graft, and closed.The patient was admitted for 4-5 days and received antibiotics.No signs of infection were reported.

• Brand Name: GUARDIAN¿ CRANIAL BURR HOLE COVER SYSTEM
• Common Device Name: DBS BURR HOLE COVER
• 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: 23334021
• Report Number: 1627487-2025-05132
• Device Sequence Number: 10637714
• Product Code: MHY
• UDI-Device Identifier: 05415067030283
• UDI-Public: (01)05415067030283(10)7684380(17)221005
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/19/2025

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: Health Professional
• Device Expiration Date: 10/05/2022
• Device Model Number: 6010
• Device Catalogue Number: 6010
• Device Lot Number: 7684380
• 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: 09/25/2025
• Initial Report FDA Received Date: 10/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2X DBS EXTENSIONS; 2X DBS LEADS; DBS BURR HOLE COVER; DBS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 47 KG