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

Model Number 3716

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

Patient Problem Purulent Discharge (1812)

Event Date 02/27/2015

Event Type  Injury  

Event Description

It was reported the patient had her scs ipg explanted as the ipg site "appeared to be infected".Reportedly, there was fluid discharge, pus, at the ipg site.In addition, the patient had previously complained of discomfort at the ipg site (ref.Mdr # 1627487-2014-23703), and the ipg being inoperable.Follow-up identified the patient's infection issue has resolved.

Manufacturer Narrative

(b)(4).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 RECHARGEABLE IPG, 16-CHANNEL
• 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
• MDR Report Key: 4627468
• MDR Text Key: 16174857
• Report Number: 1627487-2015-01101
• 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: 02/27/2015

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: Other
• Device Expiration Date: 06/01/2008
• Device Model Number: 3716
• Device Lot Number: 55418
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2006
• 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: MODEL 3186, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 36 YR