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 12/14/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Date of event is estimated.

Event Description

Related manufacturer reference number: 1627487-2020-49329.It was reported the patient experienced an infection at the burr hole site.The infection is being treated with iv antibiotics.Patient was hospitalized and had the system explanted to address the issue.

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.

• 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
• MDR Report Key: 11095355
• MDR Text Key: 224362860
• Report Number: 1627487-2020-49328
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030283
• UDI-Public: 05415067030283
• Combination Product (y/n): N
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2022
• Device Model Number: 6010
• Device Catalogue Number: 6010
• Device Lot Number: 7666604
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DBS LEAD; DBS LEAD
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 39