MAUDE Adverse Event Report: ST. JUDE MEDICAL EON MINI SPINAL CORD STIMULATOR; "STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF"

Model Number 3788

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 10/11/2018

Event Type  malfunction  

Event Description

Patient reports that the device caused harm while implanted.

• Brand Name: EON MINI SPINAL CORD STIMULATOR
• Type of Device: "STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF"
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 7999500
• MDR Text Key: 125277537
• Report Number: MW5080764
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3788
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR