MAUDE Adverse Event Report: Abbott Medical 8CH Infinity DBS Flex Extn Kit, 60cm, B; Stimulator, Electrical, Implanted, For Parkinsonian Tremor

Model Number	6372
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a routine ipg replacement (b)(6) 2026 patients extension was damaged.As a result, surgical intervention was undertaken on (b)(6) 2026 wherein extension was explanted and replaced to address the issue.

• Brand Name: 8CH Infinity DBS Flex Extn Kit, 60cm, 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: 50041425
• Report Number: 1627487-2026-09139
• Device Sequence Number: 9853529
• Product Code: MHY
• UDI-Device Identifier: 05415067030351
• UDI-Public: (01)05415067030351(10)7013177(17)210524
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• 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): 08/11/2026

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: 05/24/2021
• Device Model Number: 6372
• Device Catalogue Number: 6372
• Device Lot Number: 7013177
• 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: 06/30/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2019
• 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; DBS burr hole cap (x2); DBS extension; DBS lead (x2)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 180 LB