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

Model Number 3721

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 10/28/2014

Event Type  Injury  

Event Description

Device 1 of 3.Reference mfr report #'s 1627487-2014-00434 and 1627487-2014-00435.Information provided by the patient's attorney, indicated the patient alleges the following issues: the patient experiences overstimulation from her scs system as well as pocket heating while recharging.Additionally, the patient indicated the therapy system did not alleviate her pain.Additional information is needed to clarify the nature of the patient's issues.Sjm was made aware of the issues on 10/28/2014, and the patient's scs system has not evaluated by an sjm representative to verify and/or troubleshoot any of the reported issues.Surgical intervention will be undertaken at a later date to explant the devices.On 08/01/2012 st.Jude medical, neuromodulation division, sent field action letters to patients related to heating while charging and raised awareness of this issue to patients.An increase in prior non-reported heating while charging events and other non-reported events was expected.

Manufacturer Narrative

This device is associated with a field correction.Device evaluated by manufacturer: corrective and preventive action (capa) investigations was performed.Results: 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.Results: charger.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.

• Brand Name: EON MINI CHARGING SYSTEM
• Type of Device: SCS CHARGING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4264327
• MDR Text Key: 5295211
• Report Number: 1627487-2014-00433
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2013
• Device Model Number: 3721
• Device Lot Number: 3708620
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2012
• 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
• Treatment: SCS ANCHOR, MODEL: 1192 (2)
• Patient Outcome(s): Other
• Patient Age: 49 YR