MAUDE Adverse Event Report: REALIZE LAP BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

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

Patient Problems Abdominal Pain (1685); Dysphagia/ Odynophagia (1815); Prolapse (2475)

Event Date 09/21/2018

Event Type  Injury  

Event Description

I had a lap band in 2010.On (b)(6) 2018, i began having issues with swallowing.Food would now go down and water would only go down at a trickle.I went a few days like that until i started to have pain in my upper abdominal area and water was still only going down a few sips every few hours.I went to emergency room on (b)(6).They did a ct scan which showed no erosion but couldn't give a reason why i couldn't eat or drink.On (b)(6), i called my bariatric doctor and they and they rushed me into the office for barium swallow.That showed that only the tiniest amount of solution was going through and my doctor wanted to admit me into the hospital that night for fluids and to prep for surgery to get it removed.He mentioned i had two options and neither is good: have a homecare nurse come put an iv in and hydrate me and give me food through a feeding tube or get it out.He had also mentioned he had taken out over 700 bands before.On (b)(6) i was prepped and had surgery early that morning.The doctor said my stomach had prolapsed up above the band and constructed the ability to have anything go down.He said it would have been worse if i had waited any longer.

• Brand Name: REALIZE LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• MDR Report Key: 7947058
• MDR Text Key: 123495716
• Report Number: MW5080421
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• 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: 10/04/2018

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 34 YR
• Patient Weight: 83