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

Model Number 3788

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported the patient did not recharge the ipg as recommended.In turn, the ipg became inoperable.Surgical intervention may be pending to address the issue.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain patient¿s weight.Further information was requested but not received.The directions for use states that the implant must be charged every 30 days to avoid battery depletion.Based on the information received, the cause of the reported incident is related to user error.

Event Description

Additional information received identified that patient underwent surgical intervention on (b)(6) 2020 wherein, the ipg was explanted and replaced.Effective therapy was restored post operatively.

• 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: 10353858
• MDR Text Key: 201335263
• Report Number: 1627487-2020-23269
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734400671
• UDI-Public: 05414734400671
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2013
• Device Model Number: 3788
• Device Catalogue Number: 1192
• Device Lot Number: 3540369
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other