MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION GUARDIAN CRANIAL BURR HOLE COVER SYSTEM; DBS LEAD ACCESSORY

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	05/04/2020
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 report numbers: 1627487-2020-04883, 1627487-2020-04885, 1627487-2020-04889, 1627487-2020-04895, 1627487-2020-04896, 1627487-2020-04898, 1627487-2020-04899.It was reported an infection was present at an unknown location.As a result, surgical intervention may occur at a later date to address the issue.No further information is available at this time.
Event or Problem Description
Additional information received indicates that the infection later 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.
Event or Problem Description
Additional information received indicates that the infection was located where the patient's left lead exits the burr hole cap and an opening with drainage was observed.The patient was given medication.As a result, the patient underwent surgical intervention during which the leads were explanted.It is unknown which lead/burr hole cover was infected, so all are being reported.

• Brand Name: GUARDIAN CRANIAL BURR HOLE COVER SYSTEM
• Common Device Name: DBS LEAD ACCESSORY
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10088243
• Report Number: 1627487-2020-21035
• Device Sequence Number: 14054863
• Product Code: MHY
• UDI-Device Identifier: 05414734403061
• UDI-Public: 05414734403061
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2020

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: 06/27/2020
• Device Model Number: 6010
• Device Catalogue Number: 6010
• Device Lot Number: 6508014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 07/07/2020; 08/06/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 07/27/2020; 08/26/2020
• 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 IPG (X2); DBS LEAD (X2); DBS LEAD ACCESSORY (X3); DBS IPG (X2); DBS LEAD (X2); DBS LEAD ACCESSORY (X3)
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 101