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

Model Number	3716
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
Event or Problem Description
It was reported the patient stopped recharging her ipg as recommended.In turn, her ipg became inoperable over time.As a result, the patient may undergo surgical intervention at a later date.
Event or Problem Description
Follow up revealed that the patient's ipg was explanted and replaced to address the issue.

• Brand Name: EON RECHARGEABLE IPG, 16-CHANNEL
• Common Device Name: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 7904070
• Report Number: 1627487-2018-09079
• Device Sequence Number: 169980
• Product Code: LGW
• UDI-Device Identifier: 05414734405409
• UDI-Public: 05414734405409
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2019

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: 06/30/2007
• Device Model Number: 3716
• Device Catalogue Number: 3716
• Device Lot Number: 38831A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/12/2018; 01/28/2019
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/19/2018; 01/30/2019
• 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: 58 YR