MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B; DBS EXTENSION

Model Number	6372
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient is experiencing ineffective therapy due to high and low impedances on the leads.Patient slightly bumped their head.Surgical intervention may take place at a later date to address the issue.
Additional Manufacturer Narrative
D10 - concomitant medical products - 6662.Date of event is estimated.
Additional Manufacturer Narrative
Correction: d1 - brand name\ d4 - additional device information\ \ the report of ¿ineffective therapy¿ was not confirmed.Analysis of the returned extension (b) did not identify any anomalies or broken internal wires, and the extension passed continuity and output resistance testing.
Event or Problem Description
Additional information received indicates the extensions were explanted and replaced to address the issue.Effective therapy was established.Implanted (b)(6) of 2024.Exact date of implant is unknown.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 60CM, 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: 25552542
• Report Number: 1627487-2026-08522
• Device Sequence Number: 10741623
• Product Code: MHY
• UDI-Device Identifier: 05415067030351
• UDI-Public: 05415067030351
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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): 07/16/2026

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: 02/13/2026
• Device Model Number: 6372
• Device Catalogue Number: 6372
• Device Lot Number: 10205818
• 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: 06/05/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown