MAUDE Adverse Event Report: LAP BAND

Device Problems Entrapment of Device (1212); Device Slipped (1584)

Patient Problems Adhesion(s) (1695); Aspiration/Inhalation (1725); Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Paralysis (1997); Pneumonia (2011); Vomiting (2144)

Event Date 10/15/2013

Event Type  Injury  

Event Description

In (b)(6) 2008, i had a 4 cc lap band placed.In (b)(6) 2012, i started having problems with aspirating in my sleep which led to numerous bouts of aspiration pneumonia.Off and on for a year and a half, i continued to battle the aspirating and severe reflux i was experiencing.I made numerous trips to my pcp as well as out of town trips to gastroenterologists.Went through multiple upper endoscopes and x-rays trying to determine what was causing the aspiration.In (b)(6) 2013, it was confirmed that my lap band had slipped.All the fluid was removed from my lap band and i didn't aspirate for about a month.When it started again, it came along with not being able to consume anything but liquids.After 2 weeks of this, i finally got to the point i couldn't keep water down.I heading to my local hospital's bariatric ctr were a barium swallow was done under fluoroscopy and it was determined that i had a severe slip.I was admitted to the hospital from the surgeon's office and put on iv fluids.I was so severely dehydrated by this point that it took two bags of iv before surgery could be done to remove my lap band.Two and a half hours i was in surgery to remove the lap band and cut it free from the adhesions it had made to my stomach and liver.For the first time in months, i was finally able to eat.In (b)(6) 2013, i started vomiting.This went in every day for months.With no less than 10 visits to gastroenterologists and at least a dozen different medical tests, it was determined that i now suffer from paralysis of the esophagus at the lower end.A life long complication that is currently untreatable.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• MDR Report Key: 4360692
• MDR Text Key: 21780182
• Report Number: MW5039731
• Device Sequence Number: 1
• Product Code: LTI
• 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: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 37 YR
• Patient Weight: 134