MAUDE Adverse Event Report: ALLERGAN LAP-BAND ADJUSTABLE GASTRIC BENDING SYSTEM (UNK SIZE); IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number LAP-BAND ADJUSTABLE GASTRIC BA

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

Patient Problems Achalasia (1692); Pain (1994); Regurgitation (2259)

Event Date 01/20/2015

Event Type  Injury  

Event Description

Patient reported "developed severe gerd which was treated with medication" and "left shoulder pain", egd revealed "esophageal immotility and esophageal dysplasia"."band removed with resolution of shoulder pain and reflux.Will need laser ablation of esophagus to destroy precancerous cells and will remain at increased risk of developing esophageal cancer".These events were not confirmed by a healthcare professional.

Manufacturer Narrative

Unique identifier (udi) #: na.Taper ii.The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Based upon implant date and explant date provided by the reporter the connector type is assumed to be a taper ii.Visual examination may determine the connector type associated with this report.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Esophageal dysmotility, pain and reflux are surgical/physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for these events.No additional information has been reported to allergan regarding the catalog number, serial number, the event date, patient data or further event details.Device labeling addresses the possible outcome of esophageal dysmotility and pain as follows: "there were additional occurrences of these events that were considered to be non-serious.Other adverse events considered related to the lap-band system that occurred in fewer than 1% of subjects included: esophagitis, gastritis, hiatal hernia, pancreatitis, abdominal pain, hernia, incisional infection, infection, redundant skin, dehydration, gl perforation, diarrhea, abnormal stools, constipation, flatulence, dyspepsia, eructation, cardiospasm, hematemesis, asthenia, fever, chest pain, incision pain, contact dermatitis, abnormal healing, edema, paresthesia, dysmenorrhea, hypochromic anemia, band leak, cholecystitis, esophageal dysmotility, esophageal ulcer, esophagitis, port displacement, port site pain, spleen injury and wound infection." device labeling addresses the possible outcome of reflux as follows: "ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation and weight regain have been reported after gastric restriction procedures.".

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BENDING SYSTEM (UNK SIZE)
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capital of tx hwy bldg 1, ste 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 4886359
• MDR Text Key: 17303933
• Report Number: 3006722112-2015-00167
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Type of Report: Initial
• Report Date: 06/04/2015

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: LAP-BAND ADJUSTABLE GASTRIC BA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2015
• Initial Date FDA Received: 06/30/2015
• 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
• Patient Outcome(s): Required Intervention