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

Model Number 3788

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Stops Intermittently (1599)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

Correction number: 1627487-12192011-003-r.This ipg serial number was included in field advisories.(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.

Event Description

Device 1 of 2.Reference mfr.Report#: 1627487-2015-23612.The patient has 2 leads (from the same lot) implanted as part of his scs system.It was reported the patient is unable to feel stimulation therapy.It was also reported the patient's stimulation turns on and off by itself.Troubleshooting was unable to resolve the issue as the patient could only feel faint stimulation in the left abdomen.It was noted the patient was initially implanted for bilateral back and leg pain.Follow-up information indicated x-rays did not reveal any anomalies and diagnostic testing revealed normal impedance readings.Subsequently, the patient will undergo surgical intervention as the next course of action.

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.

Event Description

Device 1 of 2.Reference mfr.Report#: 1627487-2015-23612.Follow-up information revealed the patient underwent surgical intervention on (b)(6) 2015, where only the ipg was explanted and replaced with a different model.It was noted the patient leads appeared to be fractured and additional intervention may be undertaken to address the issue.

Event Description

Device 1 of 2.Reference mfr.Report#: 1627487-2015-23612.Follow-up intervention revealed the patient underwent surgical intervention where the patient's leads were explanted and replaced which resolved the reported issue.

• 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: 5165842
• MDR Text Key: 28854444
• Report Number: 1627487-2015-23611
• 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,consum
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2012
• Device Model Number: 3788
• Device Lot Number: 3190351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-002-R
• Patient Sequence Number: 1
• Patient Age: 68 YR