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

Model Number 3788

Device Problem Temperature Problem (3022)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient experienced a painful burning sensation while charging the ipg (date of event is unknown).The patient confirmed there was no physical heating at the ipg site, but rather soreness in the tissue.This sensation occurs approximately 15-30 minutes into charging.The issue was replicated by the sjm representative at the clinic.Reprogramming attempts, including charging with stimulation turned off, were unable to resolve the issue.Surgical intervention may take place as the next course of action.

• 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: 5499243
• MDR Text Key: 40299252
• Report Number: 1627487-2016-01245
• 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
• Type of Report: Initial
• Report Date: 02/22/2016

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: 07/31/2017
• Device Model Number: 3788
• Device Lot Number: 5202336
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2015
• 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