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

Model Number 3788

Device Problem Pocket Stimulation (1463)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report # 1627487-2014-00430.It was reported the patient (b)(6) is receiving stimulation at the ipg pocket site.In addition, the output efficacy of the patient's therapy system has reportedly deteriorated.Efforts to resolve this matter via reprogramming have been unsuccessful.A decision regarding the next course of action has not been reached.

Manufacturer Narrative

Field correction: 1627487-07262012-002-r.This ipg serial number was included in a field advisory.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: courtney weddington ; 6901 preston rd.; plano, TX 75024 ; 9725264859
• MDR Report Key: 3962493
• MDR Text Key: 4555317
• Report Number: 1627487-2014-00429
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial

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: 05/01/2011
• Device Model Number: 3788
• Device Lot Number: 2799145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-05242011-002-R
• Patient Sequence Number: 1
• Patient Age: 44 YR