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

Model Number	6371
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of even it estimated.The allegation is against 1 of 2 extensions; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: dbs extension, model: 6371, udi: (b)(4), serial: (b)(6), batch:5924027.
Event or Problem Description
It was reported that the patient experienced ineffective therapy.Diagnostics revealed high impedances on one extension.As a result, surgical intervention was undertaken wherein the extension was explanted and replaced.The investigation was unable to determine the extension that associated with the issue.
Additional Manufacturer Narrative
The reported event of ineffective therapy due to high impedances was not confirmed.As received, microscopic inspection of the lead extension showed no anomalies and the lead extension passed all functional testing.The cause of the reported event could not be ascertained.

• 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: 23830168
• Report Number: 1627487-2025-06214
• Device Sequence Number: 9288196
• Product Code: MHY
• UDI-Device Identifier: 05415067020307
• UDI-Public: (01)05415067020307(10)5924027(17)190404
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 02/17/2026

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: 04/04/2019
• Device Model Number: 6371
• Device Catalogue Number: 6371
• Device Lot Number: 5924027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown