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

Model Number 3788

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/20/2014

Event Type  Injury  

Event Description

It was reported an explanted product was received and no other info is available.

Manufacturer Narrative

This ipg serial number was included in field advisories.Evaluation results: the ipg was returned for unspecified reasons.As returned, the ipg would not communicate due to a depleted battery.The battery was recovered and the ipg communicated, charged, and was tested to manufacturing specifications using the autotester.The ipg passed all tests.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: tamka hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 4346533
• MDR Text Key: 5172462
• Report Number: 1627487-2014-22029
• 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: 11/26/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2013
• Device Model Number: 3788
• Device Lot Number: 3359258
• Other Device ID Number: 05414734402651
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/20/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/26/2014
• Initial Date FDA Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2011
• 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: 70 YR