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

Model Number 3788

Device Problems No Device Output (1435); Use of Device Problem (1670); Operating System Becomes Nonfunctional (2996)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/10/2014

Event Type  Injury  

Event Description

It was reported, the pt had not recharged the ipg since october of last year.A replacement charging system was unable to communicate with the ipg, and the programmer showed an error code and would not communicate.It was reported the ipg would be replaced at a future date.

Manufacturer Narrative

This ipg serial number was included in a field advisory.Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt'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: jennifer st. clair ; 6901 preston rd.; plano, TX 75024 ; 9725264677
• MDR Report Key: 3733637
• MDR Text Key: 19567878
• Report Number: 1627487-2014-04187
• 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: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Model Number: 3788
• Device Lot Number: 3439222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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
• Treatment: IMPLANT DATE:; SCS LEAD: MODEL 3228
• Patient Outcome(s): Other
• Patient Age: 64 YR