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

Model Number 3788

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Shaking/Tremors (2515)

Event Date 04/18/2014

Event Type  Injury  

Event Description

The pt rec'd a cervical and thoracic scs system.The pt rec'd two thoracic leads with the same lot number.The pt reported experiencing shaking when the thoracic system is activated.The pt has rsd tremors, however, the shaking is aggravated with stimulation and makes her feel exhausted.Reprogramming has been unsuccessful.F/u identified the pt underwent surgical intervention to electively explant and replace the ipg and since has rec'd effective stimulation.

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: palka sharma ; 6901 preston rd.; plano, TX 75024 ; 9725264823
• MDR Report Key: 3850542
• MDR Text Key: 4408674
• Report Number: 1627487-2014-21336
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2013
• Device Model Number: 3788
• Device Lot Number: 3578508
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/16/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2011
• 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 IPG: MODEL 3788
• Patient Outcome(s): Other
• Patient Age: 36 YR