MAUDE Adverse Event Report: MEDTRONIC INFUSE INFUSE; BONE GRAFT

Device Problem Insufficient Information (3190)

Patient Problems Nerve Damage (1979); Pain (1994); Paralysis (1997); Anxiety (2328); Injury (2348)

Event Date 03/13/2014

Event Type  Injury  

Event Description

Reporter stated that he was in a coma when 'multi label fusion' surgery was performed and is not aware of all the details regarding the device.He has been feeling paralyzed after this procedure.He further complained of nerve damage, anxiety, pain, numbness and permanent injuries.He stated that he has been on steroids, epidural injections, and watson pill for three years now.He still currently experiences these symptoms.

• Brand Name: INFUSE
• Type of Device: BONE GRAFT
• Manufacturer (Section D): MEDTRONIC INFUSE
• MDR Report Key: 5983005
• MDR Text Key: 55913670
• Report Number: MW5065065
• Device Sequence Number: 1
• Product Code: NEK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/26/2016

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 07/06/1
• Patient Weight: 100