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

Model Number 3716

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Device 1 of 2.Reference mfr.Report#: 1627487-2015-23100.It was reported the patient experienced pocket heating at the ipg site while charging.The patient also reported the site would stay warm for an extended period of time after charging.A replacement charging system was sent to the patient.Follow-up information identified the patient has received the replacement device, which resolved the reported issue.The event date is unknown at this time.This report was originally submitted on 02/25/2015 under mfr report # 1627487-2015-260170.The filing is hereby resubmitted to reflect the appropriate mfr report number.

• Brand Name: EON RECHARGEABLE IPG, 16-CHANNEL
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano, texas
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 5137469
• MDR Text Key: 27823613
• Report Number: 1627487-2015-23099
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2012
• Device Model Number: 3716
• Device Lot Number: 3145885
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-001-C
• Patient Sequence Number: 1
• Treatment: MODEL 3186, SCS LEAD (2), IMPLANT DATE
• Patient Outcome(s): Other