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

Model Number 3788

Device Problem Failure to Shut Off (2939)

Patient Problem Shaking/Tremors (2515)

Event Date 12/19/2013

Event Type  Injury  

Event Description

It was reported the pt felt stimulation when the ipg was turned off.The patient had fallen recently and it was reported the pt was experiencing tremors.The physician undertook surgical intervention and performed thorough intraoperative testing.It was reported the ipg was disconnected several times and the pt detected stimulation even when the ipg turned off.The physician opted to replace the ipg after the tasting.It was reported the pt was experiencing residual stimulation postoperative.Reprogramming resolved the issue.

Manufacturer Narrative

Sjm has limited info 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
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: jennifer st. clair ; 6901 preston rd.; plano, TX 75024 ; 9725264677
• MDR Report Key: 3629008
• MDR Text Key: 4208463
• Report Number: 1627487-2014-04040
• 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: 01/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2015
• Device Model Number: 3788
• Device Lot Number: 4003182
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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 LEAD: MODEL 3228; IMPLANTED:
• Patient Outcome(s): Other
• Patient Age: 74 YR