MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B; DBS EXTENSION

Model Number	6371
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Movement Disorder (4412)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported patient experienced ineffective therapy due to high impedances on both leads.Surgical intervention was undertaken wherein both extensions were explanted and replaced to address the issue.
Additional Manufacturer Narrative
The report of ¿ineffective therapy¿ was not confirmed.Analysis of the returned lead extension (b) did not identify any broken internal wires or outer tubing breaches, it passed end to end continuity testing and also passed inter-channel isolation testing.The root cause of the reported ineffective therapy is unknown.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B
• Common Device Name: DBS EXTENSION
• 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: 24069428
• Report Number: 1627487-2026-00238
• Device Sequence Number: 9387279
• Product Code: MHY
• UDI-Device Identifier: 05415067020307
• UDI-Public: (01)05415067020307(10)5737409(17)181128
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 03/12/2026

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: 11/28/2018
• Device Model Number: 6371
• Device Catalogue Number: 6371
• Device Lot Number: 5737409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2016
• 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
• Patient Sex: Unknown