MAUDE Adverse Event Report: ABBOTT MEDICAL GUARDIAN¿ CRANIAL BURR HOLE COVER SYSTEM; DBS BUR HOLE COVER

Model Number 6010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 10/11/2022

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.The allegation is against 1 of two products.However, it is unknown which component, therefore all potential components are being listed.Additional components potentially involved in the event include: serial: n/a.Batch: 8533012.Udi: (b)(4).Model: 6010.Guardian¿ cranial burr hole cover system.

Event Description

It was reported an infection was present at the burr hole cap site.As a result, surgical intervention took place whereby the wound was thoroughly debrided, and the burr hole cap was explanted and replaced.No further intervention is planned at this time.

Manufacturer Narrative

An infection was present at the burr hole cap site was reported to abbott.As a result, the wound was thoroughly debrided, and the burr hole cap was explanted and replaced.No further intervention is planned at this time.As a result, a device history record was performed to review and confirm the sterility of the burr hole cap cover.Based on the documents reviewed, the source of the infection remains unknown.

• Brand Name: GUARDIAN¿ CRANIAL BURR HOLE COVER SYSTEM
• Type of Device: DBS BUR HOLE COVER
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15632074
• MDR Text Key: 301997963
• Report Number: 1627487-2022-05727
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030283
• UDI-Public: 05415067030283
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6010
• Device Catalogue Number: 6010
• Device Lot Number: 8510313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DBS BURR HOLE COVER; DBS EXTENSION (X2); DBS IPG; DBS LEAD; DBS LEAD
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 82 KG