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

Model Number 3788

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

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

Event Date 09/01/2010

Event Type  Injury  

Event Description

It was reported surgical intervention was undertaken, explanting and replacing the previous scs system on (b)(6), 2008 due to unknown reasons.The patient alleges the scs system was removed in (b)(6) 2010 due to a (b)(6) infection at the implant site.The patient alleges she is currently doing well.

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.

Manufacturer Narrative

(b)(4).This ipg serial number was included in field advisories.Correction/removal numbers: 1627487-07262012-002-r; 1627487-12192011-003-r.The device history and sterilization records were reviewed.The device history and sterilization records reviewed were found to meet specifications and no anomalies related to this event were found.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 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 MINI IPG, 16-CHANNEL RECHARGEABLE
• 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; st. jude medical neuromodulation; 6901 preston road; plano TX 75024
• MDR Report Key: 4310148
• MDR Text Key: 5208581
• Report Number: 1627487-2014-01781
• 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: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/02/2015

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: Health Professional
• Device Expiration Date: 06/28/2012
• Device Model Number: 3788
• Device Lot Number: 3136266
• Other Device ID Number: 05414734402651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2015
• Initial Date FDA Received: 12/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2010
• 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 3383(2), SCS EXTENSION, IMPLANT DATE:; MODEL 3183(2), SCS LEAD, IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 45 YR