MAUDE Adverse Event Report: Abbott Medical Prodigy MRI IPG, 16CH, Rechargeable; SCS IPG

Model Number	3772
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's ipg became unable to communicate with external devices.As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the ipg was explanted and replaced to address the issue.
Additional Manufacturer Narrative
(b)(6).Date of event is estimated.

• Brand Name: Prodigy MRI IPG, 16CH, Rechargeable
• 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: 50868099
• Report Number: 1627487-2026-10143
• Device Sequence Number: 18820181
• Product Code: LGW
• UDI-Device Identifier: 05415067017093
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 12/01/2018
• Device Model Number: 3772
• Device Catalogue Number: 3772
• Device Lot Number: 5752723
• 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: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2016
• 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: Unknown