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

Model Number 3788

Device Problems Nonstandard Device (1420); Use of Device Problem (1670); Device Displays Incorrect Message (2591)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Correction numbers: this ipg serial number was included in field advisories.1627487-07262012-002-r, 1627487-12192011-003-r.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.Udi(di): (b)(4).

Event Description

The patient's reporting no current stimulation.According to the patient, she stopped using the scs system approximately a year ago due to unrelated bowel issues.Reportedly, the ipg will no longer communicate with any external devices and the patient programmer displays an error message.Subsequently, the sjm representative met with the patient and the issue was confirmed.Surgical intervention may be undertaken as the next course of action.

Event Description

Follow-up identified surgical intervention was undertaken on (b)(6) 2016 during which time the ipg was explanted and replaced.

• 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: 5278590
• MDR Text Key: 33057437
• Report Number: 1627487-2015-09062
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2011
• Device Model Number: 3788
• Device Lot Number: 2891069
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-05242011-002-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR