MAUDE Adverse Event Report: ABBOTT MEDICAL PRODIGY IPG; SCS IPG

Model Number	3799
Medical Device Problem Codes	No Apparent Adverse Event (3189); Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.E1 - reporter phone number: (b)(6).
Event or Problem Description
It was reported the patient¿s ipg was unable to communicate with external devices.A manufacturer representative confirmed the issue and the ipg deemed inoperable.Surgical intervention was undertaken wherein the ipg was explanted and replaced to address the issue.Therapy was restored post-op.
Additional Manufacturer Narrative
A patient experiencing an inoperable ipg was reported to abbott.The patient ipg was explanted and replaced.Therapy was restored.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 is consistent with the battery reaching end of life.
Additional Manufacturer Narrative
Further information was received indicating this event was a duplicate and reported in manufacturer reference number 1627487-2025-05599.

• Brand Name: PRODIGY IPG
• 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 ; 9723098000
• MDR Report Key: 23853961
• Report Number: 1627487-2025-06277
• Device Sequence Number: 5029641
• Product Code: LGW
• UDI-Device Identifier: 05414734405485
• UDI-Public: (01)05414734405485(10)5494402(17)180505
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 03/24/2026

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: 05/05/2018
• Device Model Number: 3799
• Device Catalogue Number: 3799
• Device Lot Number: 5494402
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 01/24/2026; 03/24/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/13/2026; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2016
• 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: Female