MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 30CM, 1.5, B

Model Number	6171
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Erosion (2075); Post Operative Wound Infection (2446); Fluid Discharge (2686)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a wound at the lead incision site was not healing.The wound showed healing disturbance with persistent crusting and white-creamy discharge, suggesting skin erosion and delayed healing.No device or deep tissue was exposed.A locate infection at the lead site was suspected.As such, surgical intervention took place on (b)(6) 2025 wherein a wound revision was performed with the help of an antibiotic mesh.Patient was administered antibiotics medication to treat the issue.The patient was discharged on (b)(6) 2025.Reportedly, the wound has healed.
Additional Manufacturer Narrative
Corrected data: health effect - clinical code.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: 8CH INFINITY DBS LEAD KIT, 30CM, 1.5, 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: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 22535305
• Report Number: 1627487-2025-03516
• Device Sequence Number: 18014192
• Product Code: MHY
• UDI-Device Identifier: 05415067030313
• UDI-Public: (01)05415067030313(10)9238667(17)250918
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 09/18/2025
• Device Model Number: 6171
• Device Catalogue Number: 6171
• Device Lot Number: 9238667
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2023
• 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 EXTENSION (X2); DBS IPG; DBS LEAD
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 54 KG