MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) ORBERA INTRAGASTRIC BALLOON; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number B-50000

Device Problem No Apparent Adverse Event (3189)

Patient Problems Abdominal Pain (1685); Nausea (1970); Regurgitation (2259)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No additional information has been reported to allergan regarding the model number, serial number, the event date, implant date, explant date, diagnostic testing, patient data or further event details.The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Device labeling addresses the reported event of pain as follows: possible complications of the use of the orbera¿ system include: abdominal or back pain, either steady or cyclic.Injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.Device labeling addresses the possible outcome of reflux as follows: possible complications of the orbera¿ system include: gastroesophageal reflux.Device labeling addresses the reported event of nausea as follows: possible complications of the use of the orbera¿ system include: gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Continuing nausea and vomiting.This could results from direct irritation of the lining of the stomach or as a result of the balloon blocking the outlet of the stomach.It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.Device labeling addresses the reported event of heartburn as follows: possible complications of the use of the orbera¿ system include: abdominal or back pain, either steady or cyclic.Injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.

Event Description

Patient reported motion sickness, abdominal pain, heartburn, and reflux.Medication, specifically digeplus and dramin, were used to treat the events.Device remains implanted.

• Brand Name: ORBERA INTRAGASTRIC BALLOON
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capital of texas hwy; building 1, suite 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 5250257
• MDR Text Key: 32125841
• Report Number: 3006722112-2015-00580
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 11/06/2015

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
• Device Catalogue Number: B-50000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2015
• Initial Date FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DIGEPLUS AND DRAMIN
• Patient Outcome(s): Required Intervention