MAUDE Adverse Event Report: Abbott Medical Kit Implantable Slim Tip Lead, 50cm; DRG LEAD

Model Number	MN10450-50A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced an infection at the lead site.As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the entire system was explanted to address the issue.The patient was treated with oral antibiotics, iv antibiotics, and hospitalization to address the issue.It is unknown which lead is related to this issue.
Additional Manufacturer Narrative
Date of event and patient's weight are estimated.The allegation is against 1 of 2 leads; however, it is unknown which lead; therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: kit implantable slim tip lead, 50cm, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 11271709.

• Brand Name: Kit Implantable 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 ; +1(972)309-8000
• MDR Report Key: 50897612
• Report Number: 1627487-2026-10295
• Device Sequence Number: 10761928
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: (01)05415067027153(10)11142473(17)271118
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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 Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 11142473
• 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: 08/29/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DRG IPG; DRG LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 150 LB