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 Codes	Fecal Incontinence (4571); Urinary Incontinence (4572)
Date of Event	07/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient symptoms on 24aug2026 (b)(6) (litigation department) emailed nmd complaints reporting: patient reported negligent placement of the dual lead arrangement (2 leads), 4 contact lead placement for spinal modulation of drg (spinal cord stimulator) on (b)(6) 2023; during the multiple attempts to pass the catheter during the placement of the spinal cord stimulator, negligently causing trauma that resulted in swelling of the tissue around the nerve that caused nerve impingement; negligently causing cauda equina syndrome.Patient was experiencing paresthesia in the foot associated with the inability to urinate and the inability to attain an erection.On (b)(6) 2023 doctor presented for an emergency visit for worsening numbness into right leg up to right hip, continued right leg tingling, some mild urine incontinence at the end of urination.Patient had an mri scan, negligently physician failed to insure that the patient underwent spinal cord decompression within 24 hours of the onset of symptoms; all of which resulted in permanent neurological injuries that include severe pain in the lower extremities associated with weakness, impotence and urinary and bowel incontinence.Per (b)(4) documents leg weakness and erectile dysfunction.Ps date: 24aug 2026: (b)(6) 2026 (b)(6): a search of the complaint database was performed.Other records related to this patient in the past 4 years: per-(b)(4) it was reported that the patient experienced urine and bowel incontinence after a trial implant.As a result, surgical intervention was undertaken on (b)(6) 2023 wherein the trial leads were explanted to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.

• 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 ; +1(972)309-8000
• MDR Report Key: 50859453
• Report Number: 1627487-2026-10051
• Device Sequence Number: 10026547
• Product Code: PMP
• UDI-Device Identifier: 05415067027139
• 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: 2023
• Device Explanted Year: 2023
• 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): 09/22/2026

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: 05/24/2025
• Device Model Number: MN10350-50A
• Device Catalogue Number: MN10350-50A
• Device Lot Number: 9061755
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2023
• 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: Male