MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION GUARDIAN CRANIAL BURR HOLE COVER SYS.; 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	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.During processing of this complaint, attempts were made to obtain complete event information.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Device 6 of 7: related manufacturer reference number: 1627487-2019-12554.Related manufacturer reference number: 1627487-2019-12555.Related manufacturer reference number: 1627487-2019-12556.Related manufacturer reference number: 1627487-2019-12557.Related manufacturer reference number: 1627487-2019-12558.Related manufacturer reference number: 1627487-2019-12560.It was reported the patient experienced an infection at an unknown location.To address the issue, the physician explanted the dbs system (exact date is unknown).No further details were able to be obtained.
Additional Manufacturer Narrative
A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information provided a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a device issue.

• Brand Name: GUARDIAN CRANIAL BURR HOLE COVER SYS.
• Common Device Name: DBS BUR HOLE COVER
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9310204
• Report Number: 1627487-2019-12559
• Device Sequence Number: 19884212
• Product Code: MHY
• UDI-Device Identifier: 05414734403061
• UDI-Public: 05414734403061
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

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: 04/14/2021
• Device Model Number: 6010
• Device Lot Number: 6942438
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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 ACCESSORY; DBS EXTENSION (X2); DBS IPG; DBS LEAD (X2)
• Outcome Attributed to Adverse Event: Other