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

Model Number 3716

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Blurring (2230); Weight Changes (2607)

Event Date 03/24/2014

Event Type  Injury  

Event Description

It was reported the pt lost 40lbs and as a result, the ipg protruded causing discomfort.Surgical intervention was undertaken and the ipg was explanted and replaced with a smaller device.The physician opted to replace the extension as well.Postoperatively, the pt is still healing; however, the pain has improved.

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.

• Brand Name: EON
• Type of Device: SCS IPG
• Manufacturer (Section D): ST JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: melissa nkematu ; 6901 preston rd.; plano, TX 75024 ; 9723092520
• MDR Report Key: 3783138
• MDR Text Key: 4434356
• Report Number: 1627487-2014-01230
• 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: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2013
• Device Model Number: 3716
• Device Lot Number: 3319791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• 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 LEAD: MODEL 3189 (2); SCS EXTENSION: MODEL 3386 (2); IMPLANT DATE:; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 51 YR