MAUDE Adverse Event Report: ST. JUDE MEDICAL, NEUROMODULATION EON MINI; SCS IPG

Model Number 3788

Device Problems Delayed Charge Time (2586); Communication or Transmission Problem (2896); Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 04/01/2014

Event Type  Injury  

Event Description

Device 1 of 3 - reference mfr.Reports: 1627487-2014-03484 and 1627487-2014-03485: the patient has 2 scs leads with the same lot number.It was reported, the patient experienced heating while charging, increased recharge burden, overstimulation, burning pain at the lead sites and ipg communication issues.The patient is consulting with the physician regarding surgical intervention.The manufacturer's records indicate the patient received a low energy charging system.On 08/01/2012, st.Jude medical, neuromodulation division, sent a field action letter 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.Due to the nature of litigation, these allegations cannot be confirmed or rejected.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.

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
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL, NEUROMODULATION; plano TX
• Manufacturer Contact: rachel blackwell ; 6901 preston road; plano, TX 75024 ; 9725264637
• MDR Report Key: 3961302
• MDR Text Key: 20298664
• Report Number: 1627487-2014-03483
• 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: 06/23/2014

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: 02/01/2014
• Device Model Number: 3788
• Device Lot Number: 3619781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2014
• Initial Date FDA Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• 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
• Treatment: IMPLANT DATE:; SCS ANCHOR: MODEL 1192(2)
• Patient Outcome(s): Other
• Patient Age: 46 YR