MAUDE Adverse Event Report: Abbott Medical Proclaim¿ 7 Elite Implantable Pulse Generator; SCS IPG

Model Number	3662
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient experienced pain at the ipg pocket site and ineffective stimulation.Surgical intervention took place wherein the patient¿s system was explanted to address the issue.Note: it is unknown which lead is related to this issue.
Additional Manufacturer Narrative
Date of event is estimated.The allegation is against 1 of 2 octrode lead kit, 60cm length; however, it is unknown which octrode lead kit, 60cm length, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: octrode lead kit, 60cm length, model: 3186ans, udi: unk, batch: 2793375.
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 event could not be conclusively determined.

• Brand Name: Proclaim¿ 7 Elite Implantable Pulse Generator
• Common Device Name: SCS IPG
• 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: 50934574
• Report Number: 1627487-2026-10355
• Device Sequence Number: 15852463
• Product Code: LGW
• UDI-Device Identifier: 05415067020222
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/29/2026

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: 04/01/2020
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: 6379083
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2018
• 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: SCS Lead
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 300 LB