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

Model Number	MN10450-50A
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event and patient's weight is estimated.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.During processing of this complaint, attempts were made to obtain complete device information.
Event or Problem Description
It was reported that patient's system was unable to enter mri mode.Troubleshooting revealed high impedances on the l5 lead.As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was partially removed, and a portion of the lead was left in the patient [related manufacturer reference number: 1627487-2026-01992].
Additional Manufacturer Narrative
Correction h6: health impact code should have been 4624 - surgical intervention instead of 4627 - device explantation.

• 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 ; 9723098000
• MDR Report Key: 24966763
• Report Number: 1627487-2026-01991
• Device Sequence Number: 18749040
• Product Code: PMP
• UDI-Device Identifier: 05415067025531
• UDI-Public: (01)05415067025531(10)AB2155(17)180825
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 04/28/2026

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: 08/25/2018
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: AB2155
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2017
• 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 Age: 49 YR
• Patient Sex: Female
• Patient Weight: 68 KG