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

Model Number 3788

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

This ipg serial number was included in a field advisory.(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.(b)(4).

Event Description

It was reported the patient's charger was destroyed.The patient stated she had not recharged her ipg in approximately 9 months.As a result, the patient was unable to establish communication with her ipg.The sjm representative met with the patient and confirmed the issue.The patient will consult with a physician regarding surgical intervention as the next course of action.

Event Description

Additional information received indicates that surgical intervention took place on (b)(6) 2022 wherein the ipg was explanted and replaced addressing the issue.Reportedly, therapy was confirmed post op.

Manufacturer Narrative

The patient reported failing to charge their implant properly to abbott.The device has not been returned for analysis.A review of documentation supplied with the implant 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 consistent with 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): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 5159423
• MDR Text Key: 28606734
• Report Number: 1627487-2015-23609
• 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
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Followup,Followup
• Report Date: 12/05/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2013
• Device Model Number: 3788
• Device Lot Number: 3467816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2015
• Supplement Dates Manufacturer Received: 07/21/2022; 11/22/2022
• Supplement Dates FDA Received: 08/10/2022; 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-002-R
• Patient Sequence Number: 1
• Treatment: MODEL 1192 (2), SCS ANCHOR; MODEL 3186 (2), SCS LEAD; MODEL 3186 (2), SCS LEAD
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 64 KG