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

Model Number 3788

Device Problems Nonstandard Device (1420); Low impedance (2285)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

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

Device 3 of 3: reference mfr report#1627487-2016-01026, reference mfr report#1627487-2016-01027.It was reported the patient lost stimulation in the right leg (date of event unknown).Reportedly, reprogramming was unsuccessful.Diagnostic testing revealed low impedance readings on multiple contacts.As a result, a physician consult was scheduled as well as possible x-ray imaging to further evaluate the issue.Follow-up identified surgical intervention was undertaken as the next course of action.Both leads and ipg were explanted and replaced with new models during the procedure.Stimulation was restored postoperatively.The issue is resolved.

Event Description

Device 3 of 3.Reference mfr report #1627487-2016-01026, #1627487-2016-01027.

Event Description

Device 3 of 3.Reference mfr report#1627487-2016-01026; reference mfr report#1627487-2016-01027.

• 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: 5480182
• MDR Text Key: 39666573
• Report Number: 1627487-2016-01103
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2013
• Device Model Number: 3788
• Device Lot Number: 3290712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/04/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/18/2016; 04/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2011
• 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 Outcome(s): Other