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	11/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference# 1627487-2019-13335, 1627487-2019-13332, & 1627487-2019-13334.It was reported that the patient had an infection at the right extension cover and left extension/lead connection is located.The patient was given a course of oral antibiotics in addition to intraoperative iv antibiotics.
Event or Problem Description
Further follow-up indicates the infection has resolved.
Additional Manufacturer Narrative
A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.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: 9385978
• Report Number: 1627487-2019-13333
• Device Sequence Number: 2207657
• Product Code: MHY
• UDI-Device Identifier: 05414734403061
• UDI-Public: 05414734403061
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2020

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: 12/07/2019
• Device Model Number: 6010
• Device Catalogue Number: 6010
• Device Lot Number: 6220713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 02/03/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 01/26/2020; 02/21/2020
• 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 EXTENSION (2); DBS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 50