MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI

Model Number 3788

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

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

Event Date 12/09/2013

Event Type  Injury  

Event Description

Device #1 of 2.Reference mfr.Report: 1627487-2014-26015.It was reported, the entire scs system was explanted due to the pt contracting (b)(6).The pt was hospitalized and treated with vancomycin.The pt has been released from the hospital and there are no plans to reimplant at this time.

Manufacturer Narrative

Method: the device history and sterilization records were reviewed.Results: review of the dhr found a nonconformance related to the product lot.The individual affected device was removed from the lot.All other devices within the lot met acceptance criteria.Therefore the dhr anomaly is not related to the alleged device complaint.Conclusion: the cause of the reported complaint could not be determined form 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 MINI
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: tana hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 3682917
• MDR Text Key: 4260399
• Report Number: 1627487-2014-26014
• 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: 12/14/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Model Number: 3788
• Device Lot Number: 4317929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• 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): Hospitalization; Other
• Patient Age: 44 YR