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

Model Number	6010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date: date of event is estimated.The results/method and conclusion codes along with investigation results will be provided on the final report.Further information was requested but not received.
Event or Problem Description
Related manufacturer report 1627487-2021-00213; related manufacturer report 1627487-2021-00215.It was reported that patient experienced a trauma resulting in developing a scab on the burr hole location resulting in inflammation and festering secretion.The lead and the burr hole covers were explanted.No additional information is available at this time.
Additional Manufacturer Narrative
A patient experiencing inflammation at burr hole location was reported to abbott.The patient developed a scab on the burr hole location resulting in inflammation and festering secretion.The lead and the burr hole covers were explanted.Issue has resolved.No implanted devices were returned for evaluation.The event information pertaining to this incident has been reviewed and no product investigation can be performed as there are no complaint allegations present nor were the circumstances of the event attributed to the implanted system.

• Brand Name: GUARDIAN CRANIAL BURR HOLE COVER SYSTEM
• Common Device Name: DBS BUR HOLE COVER
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11145733
• Report Number: 1627487-2021-00214
• Device Sequence Number: 846507
• Product Code: MHY
• UDI-Device Identifier: 05414734403061
• UDI-Public: 05414734403061
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: 03/23/2022
• Device Model Number: 6010
• Device Catalogue Number: 6010
• Device Lot Number: 7435297
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DBS BURR HOLE COVER; DBS LEAD; DBS BURR HOLE COVER; DBS LEAD
• Outcome Attributed to Adverse Event: Other