MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON C 16-CHANNEL IPG; SCS IPG

Model Number 3688

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

Patient Problem Edema (1820)

Event Date 11/12/2014

Event Type  Injury  

Event Description

It was reported the pt had fluid build up around the ipg.The physician opened the ipg pocket, performed an antibiotic was hand closed the pocket.Cultures were taken and were negative for infection.

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 C 16-CHANNEL IPG
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: connie timmons ; 6901 preston rd.; plano, TX 75024 ; 9723098055
• MDR Report Key: 4338210
• MDR Text Key: 5178310
• Report Number: 1627487-2014-12840
• 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: Other
• Type of Report: Initial
• Report Date: 11/12/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Model Number: 3688
• Device Lot Number: 4556686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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 3219,; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 75 YR