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

Model Number 3788

Device Problems No Device Output (1435); Use of Device Problem (1670); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/05/2014

Event Type  Injury  

Event Description

It was reported the patient's ipg became inoperable due to not charging it for about a month.A sjm representative confirmed the communication issue between the ipg and multiple external devices.Subsequently, the ipg was explanted and replaced with another model which resolved the issue.The patient is reportedly "doing well".

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; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4510571
• MDR Text Key: 5440354
• Report Number: 1627487-2015-260152
• 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: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2014
• Device Model Number: 3788
• Device Lot Number: 3737225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2015
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2012
• 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: MODEL 3208, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 51 YR