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

Model Number 3788

Device Problem Temperature Problem (3022)

Patient Problems Erythema (1840); Swelling (2091); Burning Sensation (2146)

Event Date 05/26/2015

Event Type  Injury  

Event Description

It was reported the patient alleged to experience swelling, redness and heating sensation at the scs ipg site.Subsequently, the scs ipg was explanted.Additional information is needed to clarify the nature of the patient's issues.Sjm was made aware of the issues on (b)(6) 2015 , and the patient's scs system was not evaluated by an sjm representative to verify and/or troubleshoot any of the reported issues prior to explant.

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.(b)(4).

Event Description

Additional review of the patient's medical record identified the entire scs system was explanted on (b)(6) 2015.Prior to the explant, the patient presented at the emergency room on (b)(6) 2015 for pain and redness over his ipg site.As per the physician no infection was identified and x-rays taken revealed no anomalies with the leads or ipg.

• 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; 6901 preston rd; plano TX 75024
• MDR Report Key: 4909977
• MDR Text Key: 6049896
• Report Number: 1627487-2015-20392
• 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,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 3788
• Device Lot Number: 3876648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2012
• 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 3341(2), SCS EXTENSION
• Patient Outcome(s): Other
• Patient Age: 53 YR