MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number SAGBX

Device Problems Leak/Splash (1354); Device Slipped (1584)

Patient Problems Abdominal Pain (1685); Erosion (1750); Fever (1858); Vomiting (2144); Not Applicable (3189); No Code Available (3191)

Event Date 01/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported that lap band device slipped causing erosion, inflammation of esophagus and upper stomach area.As a result of this i had a dramatic increase of gerd and problems swallowing food.Began vomiting almost every time i ate.Had to prop myself up to sleep because of gerd being so bad when trying to sleep.Had to have the device removed.Reverted to sleeve when lap band had to be removed.Test were ran in 2018 to check for leaks.Everything checked out okay.Two days later, i had severe upper abdominal pain while getting ready for bed.Woke the next morning with pain and fever.Went to er as directed by physician.Had to have emergency surgery to see what was causing the problems.They found a leak in the area where the lap band device had been located.It caused a weakened area and resulted in the leak.Also required another surgery for a total of three surgeries.They tried to repair the leak but could not get a stent placed.Even transferred me to another hospital to have another physician to see if he could repair.He was also unable to repair the leak.Had a sepsis infection and required 84 days of hospitalization and rehabilitation.Had to have a j tube placed, so i could receive nourishment and see if fissure would heal on its own.This was done in the hospital, rehabilitation facility, and continued at home.Continued rehabilitation at home as well.Fissure eventually healed with continued treatment at home.

• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8044439
• MDR Text Key: 126359181
• Report Number: 3005075853-2018-14218
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SAGBX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention