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 11/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This charger model was associated with a field correction.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.(b)(4).

Event Description

Device #1 of 2: reference mfr.Report: 1627487-2015-26654.The patient reports she is experiencing some heating discomfort at the ipg site especially during recharging.A replacement charging system (model 3722) has been 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.ࠁn increase in prior non-reported heating while charging events and other non-reported events was expected.

• 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: 5258667
• MDR Text Key: 32435834
• Report Number: 1627487-2015-26653
• 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
• Type of Report: Initial
• Report Date: 11/10/2015

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 Expiration Date: 10/28/2012
• Device Model Number: 3721
• Device Lot Number: 3528629
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2011
• 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 1192 (2), SCS ANCHOR
• Patient Outcome(s): Other
• Patient Age: 32 YR