MAUDE Adverse Event Report: ST. JUDE MEDICAL ¿ NEUROMODULATION EON PATIENT PROGRAMMER

Model Number 3851

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/25/2014

Event Type  Injury  

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.

Event Description

It was reported the patient was unable to reduce stimulation intensity by pressing the '-' button on the programmer; the stimulation intensity increased instead of decreasing.The sjm representative used a demo programmer which worked fine.A replacement programmer was sent to the patient which resolved the issue.

• Brand Name: EON PATIENT PROGRAMMER
• Type of Device: PATIENT PROGRAMMER
• Manufacturer (Section D): ST. JUDE MEDICAL ¿ NEUROMODULATION; plano TX
• Manufacturer Contact: palka sharma ; 6901 preston rd.; plano, TX 75024 ; 9725264823
• MDR Report Key: 3693096
• MDR Text Key: 21272879
• Report Number: 1627487-2014-21167
• 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: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2012
• Device Model Number: 3851
• Device Lot Number: 3244881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2010
• 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 IPG: MODEL 3788; IMPLANT:; SCS LEAD: MODEL 3228; IMPLANT:
• Patient Outcome(s): Other
• Patient Age: 37 YR