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 Problems Unspecified Infection (1930); Skin Erosion (2075)

Event Date 05/15/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number: 1627487-2021-14572, 1627487-2021-14573, 1627487-2021-14575.It was reported the patient erosion occurring on the right lead and an infection at the ipg site.In turn, the patient underwent surgical intervention wherein the entire system was explanted, and the patient was placed on iv antibiotics to address the issue.

Manufacturer Narrative

A patient had their system explanted due to infection was reported to abbott.As a result, a device history record was performed to review and confirm the sterility of devices.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
• MDR Report Key: 11938010
• MDR Text Key: 254238829
• Report Number: 1627487-2021-14574
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 07/25/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2022
• Device Model Number: 6010
• Device Catalogue Number: 6010
• Device Lot Number: 7641058
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 07/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DBS BUR HOLE COVER; DBS IPG; DBS LEAD; DBS BUR HOLE COVER; DBS IPG; DBS LEAD
• Patient Outcome(s): Other
• Patient Weight: 100