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 10/10/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2022-05984.It was reported that the patient had an infection at the lead site.Surgical intervention was undertaken on an unknown date in 2022 where the entire system was explanted.

Manufacturer Narrative

The allegation is against 1 of 2 cranial burr hole covers; however, it is unknown which cranial burr hole cover, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: dbs cranial burr hole cover, model: 6010, udi: (b)(4), serial: n/a, batch: 8026830.During processing of this incident, attempts were made to obtain complete event information.Further information was requested but not received.

Manufacturer Narrative

An event of infection was reported to abbott.It was conveyed that the infection originates at the lead site(s) and the entire system was explanted; however, no explanted products were returned for analysis.As a result, a device history record was performed to review and confirm the sterility of the lead(s).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: 15707793
• MDR Text Key: 302767104
• Report Number: 1627487-2022-05985
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2023
• Device Model Number: 6010
• Device Catalogue Number: 6010
• Device Lot Number: 8026830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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 CAP; DBS IPG; DBS LEAD
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 45 KG