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

Model Number	MN20450-50A
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Additional components potentially involved in the event include: common device name: drg lead, model: mn20450, udi: (b)(4), serial: unknown, batch: unknown during processing of this incident, attempts were made to obtain complete event and device information.Further information was requested but not received.
Event or Problem Description
It was reported that the patient experienced ineffective therapy.As such, surgical intervention took place on (b)(6) 2025 to explant the entire system.During the explant procedure, the ipg was explanted and the leads were snapped.As such, only a portion of the leads were removed and the remaining fragment of the leads remains implanted (related manufacturer reference number: 1627487-2025-02672 and 1627487-2025-02673).Investigation was unable to determine which if the leads attributed to the issue.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Corrected data: corrected the model of the additional component.Additional components potentially involved in the event include: common device name: drg lead, model: mn20450-50a, udi: (b)(4), serial: unknown, batch: unknown.

• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 22118921
• Report Number: 1627487-2025-02670
• Device Sequence Number: 4171774
• Product Code: PMP
• UDI-Device Identifier: 05415067027337
• UDI-Public: (01)05415067027337(10)AB2445(17)191130
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: 11/30/2019
• Device Model Number: MN20450-50A
• Device Catalogue Number: MN20450-50A
• Device Lot Number: AB2445
• 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: 05/11/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male