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); Post Operative Wound Infection (2446)

Event Date 04/15/2014

Event Type  Injury  

Event Description

It was reported the patient's ipg incision has been oozing since the implant date.The cultures were positive for staphylococcus.The patient is receiving intravenous antibiotics.The physician explanted the ipg, but the lead was left in situ.

Manufacturer Narrative

Method: the device history and sterilization records were reviewed.Results: the device history and sterilization records reviewed 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 the sterilization records.

• Brand Name: EON
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL NEUROMODULATION; 6901 preston rd.; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL- NEUROMODULATION; 6901 preston rd.; plano TX 75024
• Manufacturer Contact: connie timmons ; 6901 preston rd.; plano, TX 75024 ; 9723098054
• MDR Report Key: 3810533
• MDR Text Key: 4526903
• Report Number: 1627487-2014-12330
• 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: 04/15/2014

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: 06/01/2015
• Device Model Number: 3716
• Device Lot Number: 4110795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2014
• Initial Date FDA Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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
• Treatment: SCS LEAD: MODEL 3228; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 49 YR