MAUDE Adverse Event Report: Abbott Medical 8CH Infinity DBS Lead Kit, 40cm, 0.5, B; Stimulator, Electrical, Implanted, For Parkinsonian Tremor

Model Number	6172
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Ambulation or Postural Difficulties (2544); Speech Disorder (4415)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following having the second lead implanted the patient couldn't walk and experienced speech issues.Suspected potential stroke post op.Additionally, it was reported that the patient was unable to place their system into mri mode.Diagnostics revealed high impedances on the lead.Reprogramming was done to provide further symptom relief / speech improvement.
Additional Manufacturer Narrative
Date of event is estimated.Further information was requested but not yet received.

• Brand Name: 8CH Infinity DBS Lead Kit, 40cm, 0.5, B
• Common Device Name: Stimulator, Electrical, Implanted, For Parkinsonian Tremor
• 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 ; +1(972)309-8000
• MDR Report Key: 50122648
• Report Number: 1627487-2026-09254
• Device Sequence Number: 10560401
• Product Code: MHY
• UDI-Device Identifier: 05415067030320
• UDI-Public: (01)05415067030320(10)10438746(17)260729
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2026

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: 07/29/2026
• Device Model Number: 6172
• Device Catalogue Number: 6172
• Device Lot Number: 10438746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• 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 BURR HOLE CAP COVER; DBS BURR HOLE CAP COVER; DBS EXTENSION; DBS EXTENSION; DBS IPG; DBS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 170 LB