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

Model Number 3788

Device Problem Device Stops Intermittently (1599)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/15/2012

Event Type  Injury  

Event Description

It was reported the pt continues to experience a similar 'cycling' sensation with the new ipg (reference mfr report: 1627487-2012-11702).The pt reported the system randomly shuts off (2-3 times a day or every 60 seconds and he has to use the programmer and occasionally moves the ipg in the pocket to re-activate it.Diagnostics were normal.The pt stated when the system is on, he receives effective stimulation.Per the physician, this issue could be related to positional changes.The physician advised the pt to turn the scs system off to determine if explant would be an option.Further follow-up identified the pt underwent a trial on (b)(6) 2014 to address ineffective stimulation (reference mfr.Report: 1627487-2014-25400) which seemed to have resolved the cycling issue as well.The pt will be moving forward with a revision procedure.

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
• 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: 3850413
• MDR Text Key: 4613964
• Report Number: 1627487-2014-21345
• 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: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2014
• Device Model Number: 3788
• Device Lot Number: 3790465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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 LEAD: MODEL 3228; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 58 YR