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

Model Number	3688
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.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 incident could not be conclusively determined.
Event or Problem Description
Related manufacturer report: 1627487-2020-21555, related manufacturer report: 1627487-2020-21556, related manufacturer report: 1627487-2020-21557, related manufacturer report: 1627487-2020-21558, related manufacturer report: 1627487-2020-21559, related manufacturer report: 1627487-2020-21560.It was reported that patient experienced ineffective stimulation.Patient denies any traumas or falls.Programming changes have been attempted prior however was unsuccessful.Device system was explanted.No additional information is available.

• 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: 10140959
• Report Number: 1627487-2020-21554
• Device Sequence Number: 11298470
• Product Code: LGW
• UDI-Device Identifier: 05415067017369
• UDI-Public: 05415067017369
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 3688
• Device Catalogue Number: 3688
• Device Lot Number: 5265214
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/10/2020
• 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
• Patient Age: 37 YR