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 08/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This charger model was associated with a field correction.Manufacturer's evaluation: corrective and preventive action (capa) investigation was performed.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.

Event Description

Device 1 of 2.Reference mfr report: 1627487-2015-01314.It was reported the patient experiences heating while charging his scs ipg.A new charging system was sent to the patient to address the issue.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.

• 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: 5058251
• MDR Text Key: 25097605
• Report Number: 1627487-2015-01313
• 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
• Report Date: 08/06/2015

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: No Information
• Device Expiration Date: 08/28/2011
• Device Model Number: 3721
• Device Lot Number: 3178855
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2010
• 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: 45 YR