MAUDE Adverse Event Report: ABBOTT MEDICAL KIT TRIAL SLIM TIP LEAD, 50CM; DRG LEAD

Model Number	MN10350-50A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Respiratory Arrest (4461)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a trial implant procedure the patient stopped breathing.As a result, both leads were explanted on (b)(6) 2026, and the procedure was abandoned to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
Additional Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. .

• Brand Name: KIT TRIAL SLIM TIP LEAD, 50CM
• Common Device Name: DRG LEAD
• 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: 24318558
• Report Number: 1627487-2026-00700
• Device Sequence Number: 12158548
• Product Code: PMP
• UDI-Device Identifier: 05415067027139
• UDI-Public: (01)05415067027139(10)11111343(17)271104
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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
• Report Date (Section B): 02/16/2026

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 Model Number: MN10350-50A
• Device Catalogue Number: MN10350-50A
• Device Lot Number: 11111343
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 02/15/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2025
• 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 Age: 43 YR
• Patient Sex: Female
• Patient Weight: 82 KG