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	01/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported that the patient lost therapy due to ipg being inoperable.Reportedly, the patient went extended period of time without charging the ipg, rendering the ipg inoperable.Troubleshooting was unable to resolve the issue.As such, surgical intervention took place wherein the ipg was explanted and replaced with a new ipg to address the issue.Reportedly, therapy was confirmed post op.
Additional Manufacturer Narrative
The patient reported failing to charge their implant properly to abbott.The device has not been returned for analysis.A review of documentation supplied with the implant states that the implant must be charged every 30 days to avoid battery depletion.Based on the information received, the cause of the reported incident is consistent with user error.
Additional Manufacturer Narrative
Corrected data: h3.

• 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: 19044922
• Report Number: 1627487-2024-07917
• Device Sequence Number: 17947751
• Product Code: LGW
• UDI-Device Identifier: 05414734405485
• UDI-Public: (01)05414734405485(10)5239890(17)170831
• 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: 2024
• 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): 04/19/2024

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: 08/31/2017
• Device Model Number: 3799
• Device Lot Number: 5239890
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 04/16/2024; Not provided
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/18/2024; 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2015
• 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