MAUDE Adverse Event Report: EON MINI CHARGING SYSTEM; SCS CHARGER

Model Number 3721

Device Problem Temperature Problem (3022)

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

Event Date 08/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This charger model was included in a field correction.Manufacturer's evaluation: 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#1627487-2015-23511.

• Brand Name: EON MINI CHARGING SYSTEM
• Type of Device: SCS CHARGER
• MDR Report Key: 5058221
• MDR Text Key: 25097704
• Report Number: 1627487-2015-23512
• 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: 08/11/2015

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 Model Number: 3721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• 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: 53 YR