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

Model Number 3788

Device Problems Failure to Charge (1085); No Device Output (1435); Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 03/17/2015

Event Type  Injury  

Event Description

It was reported the ipg is unable to be recharged.The patient has had her scs system turned off for at least two months and has not recharged her ipg.Follow up information identified the ipg is inoperable and is unable to communicate with the external devices.Surgical intervention may be 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.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL NEUROMODULATION DIVISION; 6901 preston road; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL NEUROMODULATION DIVISION; 6901 preston dr; plano TX 75024
• MDR Report Key: 4698967
• MDR Text Key: 5726645
• Report Number: 1627487-2015-10109
• 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
• Type of Report: Initial
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2010
• Device Model Number: 3788
• Device Lot Number: 175419
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2008
• 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 3244, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 54 YR