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

Model Number 3688

Device Problem Low Battery (2584)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

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.(b)(4).

Event Description

It was reported the patient does not have stimulation on and when trying to turn her stimulation on with the patient programmer, the programmer displays a diagnostic error.A replacement patient programmer sent to the patient did not resolve the issue.Surgical intervention is planned for a later date to address the issue.

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

Follow-up identified the patient had her scs ipg replaced with a new one.The reported issue has been resolved.

• Brand Name: EON C 16-CHANNEL IPG
• 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: 5100568
• MDR Text Key: 26637057
• Report Number: 1627487-2015-01326
• 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: Other
• Type of Report: Followup
• Report Date: 09/30/2015

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: 03/28/2014
• Device Model Number: 3688
• Device Lot Number: 3652581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2012
• 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
• Patient Outcome(s): Other