MAUDE Adverse Event Report: Abbott Medical Kit Implantable Slim Tip Lead, 50cm; Dorsal Root Ganglion Stimulator For Pain Relief

Model Number	MN10450-50A
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced ineffective therapy.Diagnostic testing revealed high impedances on three leads, and x-ray imaging showed migration of the left l5 lead.As a result, surgical intervention was performed on 06jul2026.During the procedure, it was observed that the leads had become disconnected from the ipg because they had not been properly tightened into the device.Consequently, the ipg and the migrated lead were replaced, while the remaining original leads were tightened into the new ipg to address the issue.Following the procedure, the patient continued to experience ineffective therapy because the leads that were not replaced were not providing stimulation.Therefore, additional surgical intervention may be undertaken to address the remaining 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.

• Brand Name: Kit Implantable Slim Tip Lead, 50cm
• Common Device Name: Dorsal Root Ganglion Stimulator For Pain Relief
• 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: 50047077
• Report Number: 1627487-2026-09154
• Device Sequence Number: 10520879
• Product Code: PMP
• UDI-Device Identifier: 05415067025531
• UDI-Public: (01)05415067025531(10)AB2235(17)190201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 08/20/2026

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: 02/01/2019
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: AB2235
• 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: 07/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2017
• 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: Male
• Patient Weight: 175 LB