MAUDE Adverse Event Report: Abbott Medical 8CH Infinity DBS Flex Extn Kit, 50cm, B; Stimulator, Electrical, Implanted, For Parkinsonian Tremor

Model Number	6371
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the ipg replacement procedure on (b)(6) 2026 one of the extensions was inadvertently damaged.As a result, both extensions were replaced as scar tissue prevented clean removal of only one.

• Brand Name: 8CH Infinity DBS Flex Extn Kit, 50cm, 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: 50307774
• Report Number: 1627487-2026-09587
• Device Sequence Number: 13295842
• Product Code: MHY
• UDI-Device Identifier: 05415067030344
• UDI-Public: (01)05415067030344(10)7013148(17)210524
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/25/2026

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: 6371
• Device Catalogue Number: 6371
• Device Lot Number: 7013148
• 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: 07/30/2026
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 08/25/2026
• 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 LEAD x 2
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 175 LB