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

Model Number 3788

Device Problems No Apparent Adverse Event (3189); Wireless Communication Problem (3283)

Patient Problems No Consequences Or Impact To Patient (2199); Inadequate Pain Relief (2388)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported the patient's ipg may be inoperable and unable to provide therapy or communicate with external devices.In turn, surgical intervention may be taken at a later date to address the issue.

Event Description

Further information received indicates that the device met its full implant longevity of 10 years prior to the device becoming inoperable during its 11th year of operation since implant.This event is no longer deemed a reportable malfunction leading to an adverse event.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10283862
• MDR Text Key: 199104659
• Report Number: 1627487-2020-22875
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402651
• UDI-Public: 05414734402651
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2011
• Device Model Number: 3788
• Device Catalogue Number: 3788
• Device Lot Number: 2798819
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other