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); Charging Problem (2892)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Sjm 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.Sjm defers to the patient's physician regarding medical history.Udi(di): (b)(4).

Event Description

It was reported the patient has been unable to establish communication between his scs ipg and charging system for at least 5 weeks and is no longer receiving stimulation.A sjm representative confirmed the scs ipg is inoperable using multiple devices.As a result, surgical intervention will be taken at a later date to address the issue.

Manufacturer Narrative

Udi information was corrected.Initial reporter information was updated.Contact office information was updated.

Event Description

Additional information received indicated the patient underwent surgical intervention on an unknown date wherein the ipg was explanted.

Manufacturer Narrative

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.

• 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
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 5138529
• MDR Text Key: 27899248
• Report Number: 1627487-2015-03470
• Device Sequence Number: 1
• Product Code: GZB
• 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: Physician
• Type of Report: Followup,Followup
• Report Date: 08/28/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2014
• Device Model Number: 3788
• Device Lot Number: 3691795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: 03/16/2021; 08/11/2021
• Supplement Dates FDA Received: 03/18/2021; 08/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2012
• 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 Age: 47 YR