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

Model Number	3799
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported that following ecg procedure, the patient was unable connect to the ipg to turn therapy on.Replacement charger/programmer was unable to communicate/resolve the issue.As such, the ipg is inoperable.In turn, surgical intervention may take place at a later date to address the issue.
Event or Problem Description
Additional information received indicates that surgical intervention took place wherein the ipg was explanted and replaced to address the issue.Reportedly, therapy was restored post op.
Additional Manufacturer Narrative
The reported event for explant due to the ipg being inoperable was confirmed.As received, the ipg was inoperable due to a depleted battery.The battery was recovered and the ipg communicated, charged, and was tested to manufacturing specifications using the autotester.The ipg was functionally tested and passed all testing.

• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 21093091
• Report Number: 1627487-2025-00101
• Device Sequence Number: 15732851
• Product Code: LGW
• UDI-Device Identifier: 05414734405485
• UDI-Public: (01)05414734405485(10)5284457(17)171031
• 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): 05/27/2025

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: 10/31/2017
• Device Model Number: 3799
• Device Catalogue Number: 3799
• Device Lot Number: 5284457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 02/26/2025; 05/13/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/19/2025; 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2015
• 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