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

Model Number 3788

Device Problems Failure to Charge (1085); Low Battery (2584)

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

Event Date 08/12/2014

Event Type  Injury  

Event Description

It was reported the patient was unable to charge her ipg and a replacement charger did not resolve the issue.The sjm representative was able to communicate the ipg with both external devices, however; the patient's programmer displayed the ipg battery low stim off error message and the patient was unable to recharge her system due to the charger error.Surgical intervention may be pending to address this issue.

Manufacturer Narrative

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
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston road; plano, TX 75024 ; 9723098520
• MDR Report Key: 4084574
• MDR Text Key: 21998986
• Report Number: 1627487-2014-26698
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/14/2014

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: 12/01/2014
• Device Model Number: 3788
• Device Lot Number: 3875456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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: IMPLANT DATE; SCS LEAD: MODEL 3262
• Patient Outcome(s): Other
• Patient Age: 22 YR