MAUDE Adverse Event Report: ALLERGAN LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

Catalog Number B-2240

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

Patient Problems Dysphagia/ Odynophagia (1815); Muscle Spasm(s) (1966); Nausea (1970); Vomiting (2144); Weight Changes (2607)

Event Date 03/14/2014

Event Type  Injury  

Event Description

Healthcare professional reported a pt has the lap-band system and complained of nausea, dysphagia, and "epigastric spasms." the entire lap-band system is scheduled to be explanted.Follow-up info: healthcare professional reported the device was explanted and not replaced due to inconsistent weight loss and vomiting.

Manufacturer Narrative

(b)(4).The reporter indicated that the product associated with this report will not be returned for analysis.Based upon the serial number and implant date provided by the reporter the connector type is either a taper ii.Visual examination may determine the connector type associated with this report."epigastric spasms, dysphagia, vomiting, nausea, and weight fluctuation are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the potential of adverse events such as "epigastric spasms" as follows: "it is important to discuss all possible complications and adverse events with your pt.Complications which may result from the use of this product include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the pt's degree of intolerance to any foreign object implanted in the body." device labeling addresses the reported event of vomiting and nausea as follows: "nausea and vomiting may also be symptoms of stoma obstruction or a band/stomach slippage.Frequent, severe vomiting can result in pouch dilatation, stomach slippage or esophageal dilatation.Deflation of the band is immediately indicated in all of these situations.Deflation of the band may alleviate excessively rapid weight loss and nausea and vomiting, or re-operation to reposition or remove the device may be required." device labeling addresses the possible outcome of dysphagia and weight fluctuation 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 AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615867
• MDR Report Key: 3767324
• MDR Text Key: 4485647
• Report Number: 2024601-2014-00182
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2014

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 Expiration Date: 01/13/2013
• Device Catalogue Number: B-2240
• Device Lot Number: 2066154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2014
• Initial Date FDA Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• 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
• Patient Age: 37 YR
• Patient Weight: 106