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

Model Number	3688
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Facility name: (b)(6).Date of event is estimated.Date of implant: exact date unknown, implanted around 4 years ago.During processing of this complaint, attempts were made to obtain the implant date, but unable to obtain the results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that the lost therapy around 2 months ago due to ipg being inoperable.As such, surgical intervention took place on (b)(6) 2020 wherein the ipg was explanted and replaced with a new ipg.Therapy was restored.
Additional Manufacturer Narrative
Additional information: per the additional information received and the total therapy time provided by the device, the device meets or exceeds expected longevity.There is no device malfunction.Therefore, this event does not meet the reportability criteria.

• 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: 9865026
• Report Number: 1627487-2020-03054
• Device Sequence Number: 2910088
• Product Code: LGW
• UDI-Device Identifier: 05415067017369
• UDI-Public: 05415067017369
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 05/06/2020

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: 12/28/2016
• Device Model Number: 3688
• Device Catalogue Number: 3688
• Device Lot Number: 4920883
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 05/06/2020
• 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