MAUDE Adverse Event Report: ALLERGAN LAP-BAND AP; LAP BAND

Model Number B-2240

Device Problems Device Operates Differently Than Expected (2913); Extrusion (2934)

Patient Problems Abdominal Pain (1685); Erosion (1750); Chest Pain (1776); Nerve Damage (1979); Pain (1994); Vomiting (2144); Fluid Discharge (2686)

Event Date 04/17/2008

Event Type  Injury  

Event Description

On (b)(6) 2008, i had the allergan ap lapband.I numerous fills and unfills over a few years.Continuous vomiting, stomach hurt really bad also chest pains and left shoulder pain all the time.Later, i went to my lapband dr and he did a fluoroscopy and it showed that liquid was making its way outside of my stomach.I was in a lot of pain, i could drink very little w/o hurting.He put me on ciprofloxacn 500 mg.He could not do an endoscopy at the time because, he was scared of the infection going throughout my body.I was suppose to take the medicine and come back to see him in a few days.During that time, i started running a fever and in severe pain.I went in for emergency surgery on (b)(6) 2014 to have my eroded lapband removed.I spent 3 days in the hospital.After about 2 months, i was still having chest and left shoulder pain and still hurting in my stomach.Dr (b)(6) sent me to a gastroenterologist, he did an endoscopy showed a huge ulcer and also after 14 hours of no food i still had a lot of food in my stomach, at that time, he put me on reglan, protonix and carafate.I continued to hurt and he scheduled in 4 months for another endoscopy.It still showed the ulcer and this time after 15 hours of no food, i still had a full stomach.He changed me from reglan to erythromycin.He told me i had vagus nerve damage from the band erosion.As of today, i am still on those 3 medicines and my stomach continues to hurt along w/ my chest and left shoulder pain.It bothers me greatly everyday.The vagus nerve damage is permanent and i honestly think that allergan should be held responsible.Thank you.

• Brand Name: LAP-BAND AP
• Type of Device: LAP BAND
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 4569832
• MDR Text Key: 5462974
• Report Number: MW5041087
• 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: 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: B-2240
• Other Device ID Number: 13364542
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 46 YR
• Patient Weight: 70