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

Model Number	6172
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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.
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.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 21597712
• Report Number: 1627487-2025-01222
• Device Sequence Number: 8265744
• Product Code: MHY
• UDI-Device Identifier: 05415067020680
• UDI-Public: (01)05415067020680(10)8928465(17)250307
• 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: 03/07/2025
• Device Model Number: 6172
• Device Catalogue Number: 6172
• Device Lot Number: 8928465
• 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: 03/08/2023
• 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