MAUDE Adverse Event Report: St. Jude Medical - Neuromodulation (Puerto Rico, LLC) Proclaim¿ 5 Elite Implantable Pulse Generator; SCS IPG

Model Number	3660
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient system was unable to disable mri mode following an mri.An abbott representative met with the patient and was able to successfully disable the patient¿s ipg from mri mode using an orion exit tool (oet).Once the ipg was taken out of mri mode, the patient controller and/or clinician programmer were able to bond with the ipg, and restored therapy.
Additional Manufacturer Narrative
Date of event is estimated based on information obtained the device is included in the neuromodulation implantable pulse generator (ipg) unable to exit mri mode advisory notice issued by abbott on (b)(6)2023.Based on the information received, the event is consistent with the loss of the bluetooth pairing bond while in mri mode.As a result of this finding, abbott is performing further investigation.

• Brand Name: Proclaim¿ 5 Elite Implantable Pulse Generator
• Common Device Name: SCS IPG
• Manufacturer (Section D): St. Jude Medical - Neuromodulation (Puerto Rico, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): St. Jude Medical - Neuromodulation (Puerto Rico, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; +1(972)309-8000
• MDR Report Key: 50951052
• Report Number: 3006705815-2026-05884
• Device Sequence Number: 9552583
• Product Code: LGW
• UDI-Device Identifier: 05415067031419
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Recall,Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2025
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000151409
• 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: 09/14/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1627487-07/07/2023-001-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS LEAD
• Patient Sex: Female
• Patient Weight: 140 LB