MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI

Model Number 3788

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586); Temperature Problem (3022)

Patient Problems Shock (2072); Burning Sensation (2146)

Event Date 12/09/2013

Event Type  Injury  

Event Description

Device 1 of 3.Ref mfr.Reports: 1627487-2014-03001 and 1627487-2014-03002.It was reported the pt experienced heating while charging, shocking and the inability of her scs ipg to hold a charge.At this time, it is not clear whether the shocking issue is regarding the scs ipg or the scs lead; therefore, the scs lead is being reported as device 3.The issues remain unresolved despite multiple reprogramming and a replacement charging system.Surgical intervention (ref mrf.Report: 1627487-2013-19585) will be taken at a later date to address the issues.On 08/01/2012 st.Jude medical, neuromodulation division, sent field action letters to pts related to heating while charging and raised awareness of this issue to pts.An increase in prior non-reported heating while charging events and other non-reported events was expected.

Manufacturer Narrative

This ipg serial number was included in a field correction.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
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: rachel blackwell ; 6901 preston rd.; plano, TX 75024 ; 9725264637
• MDR Report Key: 3674142
• MDR Text Key: 4302024
• Report Number: 1627487-2014-03000
• 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: Other
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/09/2013

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: 06/01/2014
• Device Model Number: 3788
• Device Lot Number: 3740447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2013
• Initial Date FDA Received: 01/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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
• Patient Outcome(s): Other
• Patient Age: 47 YR