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

Model Number 3716

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

Patient Problems Bacterial Infection (1735); Staphylococcus Aureus (2058); Post Operative Wound Infection (2446)

Event Date 07/12/2014

Event Type  Injury  

Event Description

It was reported the pt was experiencing pain at the previous ipg site (reference mfr.Report: 167487-2014-26282).A ct scan was taken and showed a small collection of fluid which was thought to be a seroma.The physician advised the pt to wear an abdominal binder to apply pressure to the seroma which did not resolve the issue.Follow up information identified the pt under went surgical intervention to explant the entire system due to a staphylococcus infection at the ipg site.The pt is being treated with iv antibiotics via a picc line.

Manufacturer Narrative

Method: the device history and sterilization records were reviewed.Results: the device history and sterilization records reviewed were found to meet specifications and no anomalies related to this event were found.Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records.Sjm has limited information 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
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 4147422
• MDR Text Key: 18037273
• Report Number: 1627487-2014-26806
• 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: 09/11/2014

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: 04/01/2016
• Device Model Number: 3716
• Device Lot Number: 4548131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 10/02/2014
• 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: IMPLANT DATE:; SCS EXTENSIONS: MODEL 3383; IMPLANT DATE:; SCS LEAD: MODEL 3186
• Patient Outcome(s): Other
• Patient Age: 40 YR