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

Model Number	MN10350-50A
Medical Device Problem Codes	High impedance (1291); Separation Failure (2547)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported during a drg trial, there was high impedances, and one lead was stuck.As a result, the lead was removed and replaced.The procedure was completed with a new trial lead.
Additional Manufacturer Narrative
The reported event of high lead impedances was confirmed.The lead was received complete.Microscopic inspection revealed that the lead was kinked with all wires broken at 2.5cm distal to the terminal end.All channels measured open due to the broken wires.The damaged lead is consistent with an overstress condition that occurred during the procedure.

• 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: 23560479
• Report Number: 1627487-2025-05605
• Device Sequence Number: 10114214
• Product Code: PMP
• UDI-Device Identifier: 05415067027139
• UDI-Public: (01)05415067027139(10)10966459(17)270731
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 03/23/2026

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: 10966459
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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 Sex: Female