MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B

Model Number	6172
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was admitted to the emergency department due to purulent discharge from the incision site on the head.As such, surgical intervention took place wherein the entire system was explanted and a saline solution wash was performed to address the issue.Reportedly, the infection was only on the right lead and extension.Patient was hospitalized and intravenous medication was administered to treat the infection.
Additional 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.
Event or Problem Description
Additional information received indicates that the infection was just at a single site (right site).Reportedly, the infection has been resolved and the patient had been discharged from the hospital.The serial number for the right lead and extension are (b)(6).The lot number for the right burr hole cap system is 10161274.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B
• Common Device Name: DBS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 21597719
• Report Number: 1627487-2025-01223
• Device Sequence Number: 18362348
• Product Code: MHY
• UDI-Device Identifier: 05415067020680
• UDI-Public: (01)05415067020680(10)10119412(17)251211
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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: 12/11/2025
• Device Model Number: 6172
• Device Catalogue Number: 6172
• Device Lot Number: 10119412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DBS IPG.
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown