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

Model Number 3788

Device Problem Pocket Stimulation (1463)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 01/20/2014

Event Type  Injury  

Event Description

It was reported the pt was experiencing stimulation at the ipg pocket site sporadically.The pt reported the issue was dealt with by keeping the stimulation amplitude lower.If the amplitude was raised, the pt experienced overstimulation at the ipg site.Reprogramming was attempted, but did not resolve the issue.It was reported an x-ray was the next course of action.

Manufacturer Narrative

Sjm has limited information related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt'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: jennifer st. clair ; 6901 preston road; plano, TX 75024 ; 9725264677
• MDR Report Key: 3701282
• MDR Text Key: 4333595
• Report Number: 1627487-2014-04107
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 01/27/2014

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: 12/01/2014
• Device Model Number: 3788
• Device Lot Number: 3878214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2014
• Initial Date FDA Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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
• Treatment: SCS ANCHOR: MODEL: 1192 (2); IMPLANT DATE:; IMPLANT DATE:; SCS LEAD: MODEL: 3186 (2)
• Patient Outcome(s): Other
• Patient Age: 46 YR