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

Model Number 3788

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Inflammation (1932)

Event Date 04/02/2014

Event Type  Injury  

Event Description

It was reported during the postoperative meeting with the pt.The pt's arm was swollen.It was believed the swelling was due to iv infiltration and the pt was kept for observations.Follow-up on (b)(6) 2014, identified the pt's spouse reported the pt still had significant bruising on both arms.Additional follow-up on (b)(6) 2014 identified the bruising and swelling has resolved.In addition, the pt reported receiving effective stimulation therapy.

Manufacturer Narrative

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: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 3798964
• MDR Text Key: 4380842
• Report Number: 1627487-2014-02284
• 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
• Type of Report: Initial
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: 3788
• Device Lot Number: 4405815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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: IMPLANT DATE:; SCS EXTENSION: MODEL 3383 (X2); IMPLANT DATE:; SCS LEAD: MODEL 3228
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR