MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3788

Device Problems Temperature Problem (3022); Unintended Movement (3026)

Patient Problem Burning Sensation (2146)

Event Date 01/21/2015

Event Type  Injury  

Event Description

Additional information received identified the patient underwent surgical intervention to explant and replace her scs ipg.The patient's issues were reportedly resolved postoperative.

Manufacturer Narrative

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

It was reported the patient experienced a fall and subsequently began to feel a burning sensation in her scs ipg pocket after stimulation was on for approximately two hours.An sjm representative met with the patient and noted the ipg appeared to be tilted but the ipg site felt a normal temperature to the touch.An impedance check was run and all contacts were within normal limits.The patient will follow-up with her physician as the next course of action to address the issue.

Manufacturer Narrative

(b)(4).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 IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• 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: 4563487
• MDR Text Key: 5774731
• Report Number: 1627487-2015-06089
• 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
• Type of Report: Initial,Followup
• Report Date: 04/07/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 3788
• Device Lot Number: 4414143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 03/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MODEL 3214, SCS LEAD; MODEL 1192, SCS ANCHOR
• Patient Outcome(s): Other
• Patient Age: 28 YR