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

Model Number 3722

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 08/22/2017

Event Type  Injury  

Manufacturer Narrative

This charger model was associated with a field correction.Corrective and preventive action (capa) investigation was performed.Evaluation codes: result: 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: 1627487-2017-05126.It was reported the patient is experiencing discomfort described by the patient as heating at the ipg pocket site that radiates while recharging the ipg.The patient reports the pocket site is hot to touch.The patient was advised to turn the stimulation off while recharging the ipg.A replacement charging system was sent to the patient.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.The organization has made the decision to include the charging system with regard to heating while charging issues related to this letter.The charging system has been added to this event as a new device report with the supplemental information regarding the ipg.

Event Description

Device #2 of 2: reference mfr.Report: 1627487-2017-05126.Follow up information identified the patient continues to experience warmth during recharging.The replacement charging system did not resolve the issue.The patient is following up with the physician.

Event Description

Device #2 of 2: reference mfr.Report: 1627487-2017-05126.Follow up information identified the surgical intervention may be pending to address this issue.

Event Description

Device #2 of 2: reference mfr.Report: 1627487-2017-05126.Follow up information identified the patient underwent surgical intervention on (b)(6) 2017 where the ipg was removed and replaced.

Event Description

Device #2 of 2: reference mfr.Report: 1627487-2017-05126.Upon further investigation it was determined the charger model was 3722 not 3721 thus we are retracting the previous information regarfdng the fsca related to pocket heating.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 6863426
• MDR Text Key: 86068076
• Report Number: 1627487-2017-05127
• 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,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2014
• Device Model Number: 3722
• Device Lot Number: 4096571
• Other Device ID Number: 05414734405300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/30/2013
• 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: 61 YR