MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI CHARGING SYSTEM; SCS CHARGER

Model Number 3721

Device Problem Temperature Problem (3022)

Patient Problems Burning Sensation (2146); Discomfort (2330)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

This charger model was associated with a field correction.(b)(4).Corrective and preventive action (capa) investigation was performed.Pocket heating was confirmed.The investigation for capa (b)(4) associated with heating while charging (pocket heating) concluded that the charger was capable of transferring energy to the ipg at a rate that would cause heating of the ipg and/or charging wand of sufficient elevated temperature to cause pain and burns.The heating while charging was determined to be exacerbated by off-axis charging of shallow implanted ipgs and that all chargers were capable of elevated heating.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.

Event Description

Device 2 of 2: reference mfr report: 1627487-2016-01219.It was reported the patient complained her scs ipg was getting "hot".The patient stated she turns her stimulation off at times because the heat becomes uncomfortable.The pateint also stated that charging with the stimulation on makes the sensation worse.A sjm representative met with the patient but a system diagnostics did not show any abnormalities.Follow-up identified surgical intervention is planned to address the issue.

Manufacturer Narrative

Corrected data: the 'date of this report' was incorrectly reported as (b)(6) 2016.The correct date should be (b)(6) 2016.

Event Description

Device 2 of 2: reference mfr report: 1627487-2016-01219.

• Brand Name: EON MINI CHARGING SYSTEM
• Type of Device: SCS CHARGER
• 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: 5502542
• MDR Text Key: 40387645
• Report Number: 1627487-2016-01311
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/28/2013
• Device Model Number: 3721
• Device Lot Number: 3844883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2012
• 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
• Patient Outcome(s): Other
• Patient Age: 42 YR