MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION GUARDIAN CRANIAL BURR HOLE COVER SYS.; DBS BURR HOLE CAP

Model Number	6010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	10/30/2018
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
Device 3 of 3: mfr reference report: 1627487-2018-12113, and 1627487-2019-01407.It was reported that the patient had a head wound healing issue.The full system was explanted on (b)(6) 2018.
Event or Problem Description
Device 3 of 3: mfr.Reference report: 1627487-2018-12113, and 1627487-2019-01407.
Event or Problem Description
Device 3 of 3: mfr reference report: 1627487-2018-12113, and 1627487-2019-01407.It was reported that the wound issue is resolved.

• Brand Name: GUARDIAN CRANIAL BURR HOLE COVER SYS.
• Common Device Name: DBS BURR HOLE CAP
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8296567
• Report Number: 1627487-2019-01408
• Device Sequence Number: 13939871
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2019

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: 12/07/2019
• Device Model Number: 6010
• Device Lot Number: 6220713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 04/04/2019; 05/01/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 04/24/2019; 05/03/2019
• 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: MODEL 6172 DBS LEAD (X2)
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 78