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

Model Number 3716

Device Problem Pocket Stimulation (1463)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Weight Changes (2607)

Event Date 05/07/2008

Event Type  Injury  

Event Description

It was reported the patient experiences a jolting sensation when he communicates with his scs ipg using the patient programmer.The patient stated that the ipg turns on fine but when he goes to communicate with the programmer a second time he experiences three jolts at his ipg site.In additional, the patient has lost a significant amount of weight and he is now experiencing pain at his ipg site.Surgical intervention is planned for a later date to address the issues.

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: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 4212771
• MDR Text Key: 5037906
• Report Number: 1627487-2014-02751
• 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: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2010
• Device Model Number: 3716
• Device Lot Number: 116319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2008
• 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
• Patient Outcome(s): Other
• Patient Age: 41 YR