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

Model Number 3788

Device Problems Improper or Incorrect Procedure or Method (2017); Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 05/13/2018

Event Type  Injury  

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 Description

It was reported the patient experienced heating when charging their ipg.Hence the patient stopped charging the ipg and turned off the stimulation.Surgical intervention may be undertaken to address the issue.

Event Description

Additional information received identified that patient tripped over the cord and reportedly broke her hip.Patient went to the er to rule out hip fracture.As such, surgical intervention is pending.

Manufacturer Narrative

Patient weight.Device manufacture date: the device information has been corrected to reflect new information.

Event Description

Additional information was received that the ipg became inoperable due to lack of recharging as recommended.Surgery occurred during which the ipg was explanted and replaced.Post-operatively, therapy was restored.

Manufacturer Narrative

The directions for use states that the implant must be charged every 30 to 90 days to avoid battery depletion.  based on the information received, the cause of the reported incident is related to user error.

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
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; santana industrial park; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: seema wakdikar ; 9725268205
• MDR Report Key: 7662228
• MDR Text Key: 113153072
• Report Number: 3006705815-2018-01554
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017093
• UDI-Public: 05415067017093
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2011
• Device Model Number: 3788
• Device Catalogue Number: 3788
• Device Lot Number: 2773832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 79