MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON C 16-CHANNEL IPG; SCS IPG

Model Number	3688
Medical Device Problem Codes	Therapeutic or Diagnostic Output Failure (3023); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of the event is estimated.During processing of this incident, attempts were made to obtain complete device information.It is believed the ipg was implanted in 2016.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported the patient¿s ipg became inoperable around (b)(6) 2019.To address the issue, the physician explanted the ipg and replaced it with a new model, which resolved the issue.
Additional Manufacturer Narrative
The reported event of inoperable ipg was confirmed.As received, the ipg did not communicate with lab utilities.Since the patient parameters were not provided, an estimate of longevity could not be performed.Electrically the device operated within expectation during analysis.
Additional Manufacturer Narrative
Correction, h6: device and results code.

• Brand Name: EON C 16-CHANNEL IPG
• Common Device Name: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10574487
• Report Number: 1627487-2020-31404
• Device Sequence Number: 3138826
• Product Code: LGW
• UDI-Device Identifier: 05415067017369
• UDI-Public: 05415067017369
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 3688
• Device Catalogue Number: 3688
• Device Lot Number: 5016147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/29/2020; 11/20/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 11/10/2020; 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other