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

Model Number	3788
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results /method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference number: 1627487-2020-21620, related manufacturer reference number: 1627487-2020-22408.It was reported that the patient experienced ineffective stimulation.Diagnostics indicated high impedance readings on two contacts.Reprogramming was unable to resolve the issue.As such, surgical intervention took place on (b)(6) 2020 wherein the patient's ipg and extension were explanted.A new ipg was implanted to address the issue and achieve new technology.No intervention was taken on the lead.Post operatively, the lead continued to show high impedance on 2 contacts.However, the patient was programmed and therapy covers the pain area resolving the issue.
Additional Manufacturer Narrative
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.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• Common Device Name: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10222310
• Report Number: 1627487-2020-22407
• Device Sequence Number: 11580966
• Product Code: LGW
• UDI-Device Identifier: 05415067017307
• UDI-Public: 05415067017307
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: 06/30/2018
• Device Model Number: 3788
• Device Catalogue Number: 3788
• Device Lot Number: 5878663
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS EXTENSION; SCS LEAD; SCS EXTENSION; SCS LEAD
• Outcome Attributed to Adverse Event: Other