MAUDE Adverse Event Report: MRI

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Metal Shedding Debris (1804)

Patient Problems Burn(s) (1757); Headache (1880); Pain (1994); Tissue Damage (2104); Complaint, Ill-Defined (2331)

Event Date 10/14/2014

Event Type  Injury  

Event Description

I was basically burnt on the inside from having mri at the (b)(6)! this was due to a old spinal cord stimulator and leads that were implanted back in 2003.An x-ray was done prior to the mri and was noted that leads/wires were present in lower back area leading up the spine.But i was unaware that these were even still in my body until all this happened! i'm still seeing doctors concerning these injuries and am still unsure just how severe they are! but people like me should be warned and also protected from things like this ever happening! my back problems are a huge part of my medical records that have been available to them and many written by them, for many years now.No real excuse for this happening!.X-ray and ct were done as follow up and both mention the leads now appear to be in pieces located throughout my spinal card area and the metal paddle that was once against my spinal cord is now been pulled loose and could continue to migrate causing more serious spinal cord injuries etc.It appears to have done significant tissue damage causing much pain through my spine from neck to butt bone! also been experiencing daily bad headaches, mainly when lying down.

• Brand Name: MRI
• Type of Device: MRI
• MDR Report Key: 4222404
• MDR Text Key: 5067768
• Report Number: MW5038904
• Device Sequence Number: 1
• Product Code: LNH
• 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: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 55 YR
• Patient Weight: 90