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 Codes	Inadequate Pain Relief (2388); Movement Disorder (4412)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient's system was unable to enter mri mode.Troubleshooting revealed low impedances on both leads.As a result, surgical intervention may be undertaken to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.
Additional Manufacturer Narrative
E1 update: the reporter¿s information was updated.H6 correction: health effect - clinical code should be 4412 - movement disorder rather than 2388 - inadequate pain relief.
Event or Problem Description
Additional information indicates the patient experienced ineffective therapy.Additionally, surgical intervention was undertaken on (b)(6) 2026 wherein the extensions were explanted and replaced to address the issue.

• 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: 24885902
• Report Number: 1627487-2026-01833
• Device Sequence Number: 13224454
• Product Code: MHY
• UDI-Device Identifier: 05415067030351
• UDI-Public: (01)05415067030351(10)10322669(17)260501
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Model Number: 6372
• Device Catalogue Number: 6372
• Device Lot Number: 10322669
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 07/13/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/11/2026; 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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 IPG.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 84 KG