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

Model Number 3788

Device Problems Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Date 08/07/2013

Event Type  Injury  

Event Description

It was reported the pt was experiencing a shocking sensation at the ipg site which would travel up both of the lateral sides of his back.The pt reported the sensation would happen when he would lean against the ipg against a wall or object.The sjm rep met with the pt and determined the impedances were normal.X-rays did not detect any anomalies.The physician referred the pt to an orthopedic spine surgeon.It was reported the physician planned to undertake surgical intervention to address the issue at the ipg site.

Manufacturer Narrative

Correction numbers - 1627487-12192011-003-r and 1627487-07262012-002-r.This ipg serial number was included in field advisories.Sjm has limited info 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: jennifer st clair ; 6901 preston rd.; plano, TX 75024 ; 9725264677
• MDR Report Key: 3764275
• MDR Text Key: 4468757
• Report Number: 1627487-2014-04197
• 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: 03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2010
• Device Model Number: 3788
• Device Lot Number: 175419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2008
• 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
• Treatment: SCS LEAD: MODEL 3208; SCS LEAD: MODEL 3240; IMPLANT DATE:; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 56 YR