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	Post Operative Wound Infection (2446)
Date of Event	01/14/2020
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 date is an estimation.
Event or Problem Description
Related manufacturer reference number: 1627487-2020-00928; related manufacturer reference number: 1627487-2020-00930; related manufacturer reference number: 1627487-2020-00931; related manufacturer reference number: 1627487-2020-00932; related manufacturer reference number: 1627487-2020-00934; related manufacturer reference number: 1627487-2020-00935.It was reported that the patient had an infection at the ipg and cranial sites.As a result, the physician administered antibiotics prior to the procedure and revised the incision sites.No product was explanted.
Additional Manufacturer Narrative
The device history record was reviewed to ensure proper packaging and sterility.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that the physician believes that the patient's infection has cleared.

• 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: 9646198
• Report Number: 1627487-2020-00929
• Device Sequence Number: 714077
• Product Code: MHY
• UDI-Device Identifier: 05414734403061
• UDI-Public: 05414734403061
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K152342
• 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
• Report Date (Section B): 02/27/2020

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: 06/19/2020
• Device Model Number: 6010
• Device Catalogue Number: 6010
• Device Lot Number: 6498942
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/27/2020
• 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 BURR HOLE COVER; DBS EXTENSION X 2; DBS IPG; DBS LEAD X 2
• Outcome Attributed to Adverse Event: Other