MAUDE Adverse Event Report: INTERSECT ENT INC PROPEL MOMETASONE FUROATE IMPLANT

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Pain (1994); Sleep Dysfunction (2517)

Event Date 12/01/2014

Event Type  Injury  

Event Description

My name is (b)(6).I would like to relay my bad experience with the propel mometasone furoate implant.On (b)(6) 2014, i had a sleep study to determine if i had sleep apnea.When i was fitted for a cpap and my sinuses were pressurized, i immediately experienced significant sinus pain.This pain continued for several months until i was referred to dr (b)(6).He found my frontal and ethmoid sinuses to be blocked and immediately scheduled me for surgery.The surgery went well and was successful and propel implants were installed.Upon awakening from anesthesia, i experienced the worst pain i've ever felt.My pain could not be controlled and it was thought the surgery triggered a cluster headache, which i was prone to.I was discharged and sent home to take my cluster headache medications, which had no effect.I eventually had to be taken by ambulance to the er to get my pain under control.This severe pain continued.It was unlike any headache i'd experienced previously.It was centered in the area of my frontal and ethmoid sinuses.Six days after surgery, the propel implant on the left side fell out.I was the first.I had a post op appointment with dr (b)(6).He stated he'd never had a propel implant come out.I was the first.I made complaint about my pain and his opinion was it was from the surgery and it was aggravating my cluster headaches.My severe pain continued and prevented me from sleeping or returning to work.Fourteen days after surgery, i woke up with unbearable pain.This was three days after completing my post op antibiotics so i feared i might have developed an infection.I saw my personal physician who felt i may be correct, but referred my back to dr (b)(6).Fifteen days after surgery and still in incredible pain, i saw dr (b)(6).No infection was found and my sinuses looked liked they were healing very well.No reason was found for my continued pain.I was referred across town to my neurologist, who was not able to work me in, so once again i had to go to the er to get my pain to a tolerable level.Sixteen days after surgery, i saw my gp again and requested a referral to a pain specialist.Seventeen days put and my incapacitating pain continued.On the evening of the seventeenth day after surgery, the right propel implant fell out while rinsing my sinuses.My severe pain immediately stopped.I do not believe the product to be defective in any way.While i had them, they did a good job of keeping my sinuses open.My theory is that i am susceptible to contact point headaches and the presence of the implants pressing on my sinus tissue caused me severe pain.This thought didn't occur to me (or anyone) until the second implant fell out.Having the implants removed probably would have alleviated my disabling pain.I am following up with a pain specialist to see if this is a valid theory.I have a life-long history of sinus pain and cluster headaches.I regret experiencing 17 days of the worst pain i've ever felt.I am relaying this info with hope that you can learn from my experience and educate the users of the propel mometasone furoate implant that serious pain may be experienced by some pts.In such a case, they should probably be removed.I'd be happy to answer any questions by email or phone.Sincerely, (b)(6).

• Brand Name: PROPEL MOMETASONE FUROATE IMPLANT
• Type of Device: PROPEL MOMETASONE FUROATE IMPLANT
• Manufacturer (Section D): INTERSECT ENT INC
• MDR Report Key: 4364774
• MDR Text Key: 5259222
• Report Number: MW5039799
• Device Sequence Number: 1
• Product Code: OWO
• 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: 12/20/2014

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 49 YR
• Patient Weight: 111