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

Model Number 3788

Device Problems Nonstandard Device (1420); Charging Problem (2892)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2016

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

It was reported the patient experienced difficulty charging the ipg.Troubleshooting was attempted with an alternate charger to no avail.Reportedly, the patient programmer successfully communicates with the ipg; however an error message is displayed.Surgical intervention may be undertaken as the next course of action.

Event Description

Follow-up identified surgical intervention was undertaken during which time the ipg was explanted and replaced with a new model.Stimulation was restored thus resolving the 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: 5457595
• MDR Text Key: 38960562
• Report Number: 1627487-2016-00854
• 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,Followup
• Report Date: 06/01/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2013
• Device Model Number: 3788
• Device Lot Number: 3359113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2016
• Initial Date FDA Received: 02/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/06/2016; 05/18/2016; 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2011
• 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
• Patient Age: 58 YR