MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 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	Unspecified Infection (1930)
Date of Event	03/05/2020
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
Related manufacturer reference# 1627487-2020-03084.It was reported that the patient has a possible infection at the connector on the skull.Cultures were taken.The next course of action has yet to be determined.
Event or Problem Description
Additional follow up information found the patient was treated with antibiotics and no infection was found.
Additional Manufacturer Narrative
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. .

• Brand Name: GUARDIAN¿ CRANIAL BURR HOLE COVER SYSTEM
• Common Device Name: DBS BUR HOLE COVER
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9863876
• Report Number: 1627487-2020-03083
• Device Sequence Number: 11606763
• Product Code: MHY
• UDI-Device Identifier: 05414734403061
• UDI-Public: 05414734403061
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2020

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: 01/12/2020
• Device Model Number: 6010
• Device Catalogue Number: 6010
• Device Lot Number: 6273781
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 04/09/2020; 05/06/2020
• Initial Report FDA Received Date: 03/22/2020
• Supplement Report FDA Received Date: 04/27/2020; 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Weight: 73