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 Problems Itching Sensation (1943); Device Overstimulation of Tissue (1991)

Event Date 11/04/2014

Event Type  Injury  

Event Description

It was reported the patient experienced power surges when turning the stimulation on and the patient had a "break-out" and itching on his back and abdomen.Surgical intervention is planned to address the issue.

Event Description

It was reported the patient's ipg was explanted.The patient was seen 13 days following the explant and the rash persists.Note the patient has had the allergic reaction for years and it is not localized to the ipg site.

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.

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.

• 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: 4827517
• MDR Text Key: 5841808
• Report Number: 1627487-2015-12300
• 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
• Type of Report: Initial,Followup
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 3716
• Device Lot Number: 3615043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2012
• 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 3219, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 65 YR