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

Model Number 3788

Device Problems Failure to Charge (1085); Failure to Conduct (1114); Use of Device Problem (1670)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

It was reported the patient last recharged her ipg in (b)(6) 2014 and the ipg is unable to communicate with her charging system.A st.Jude representative confirmed a spare programmer was unable to communicate with her ipg and displayed error message.It is unknown when the patient lost stimulation.Surgical intervention is pending to address this issue.

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.

Event Description

Follow up information identified the patient underwent surgical intervention on (b)(6) 2016 to remove and replace her ipg which resolved the issue.

Manufacturer Narrative

(b)(4).

Event Description

Further information identified the patient experienced pocket heating while recharging.All issues were resolved with explant.

• 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: 4540392
• MDR Text Key: 5508437
• Report Number: 1627487-2015-26085
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2013
• Device Model Number: 3788
• Device Lot Number: 3546773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2011
• 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 1192 (2), SCS ANCHOR
• Patient Outcome(s): Other