MAUDE Adverse Event Report: ALLERGAN LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE); LTI

Catalog Number LAP-BAND ADJUSTABLE GASTRIC BA

Device Problem Fluid/Blood Leak (1250)

Patient Problems Failure of Implant (1924); Inflammation (1932); Weight Changes (2607)

Event Date 04/29/2014

Event Type  malfunction  

Event Description

Healthcare professional reported a lap-band "hole in the balloon of the band" first noticed when the patient reported "not losing weight and starting to gain weight".Healthcare professional also reported "inflammation of the gastric mucosa of the proximal stomach".The lap-band system is scheduled to be removed and replaced.

Manufacturer Narrative

Medwatch sent to fda on: 09/25/2014.The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Based upon the implant 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.The reported events are surgical and physiological complications, and an analysis of the device generally does not assist allergan in determining a probable cause for this event.No additional info has been reported to allergan regarding the serial number or model number.Inadequate weight loss is addressed in the labeling.Allergan does not guarantee that every patient will achieve desired weight loss.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Type of Device: LTI
• Manufacturer (Section D): ALLERGAN; goleta CA
• Manufacturer (Section G): UNK ALLERGAN; 71 south los carneros road; goleta CA 93111
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615867
• MDR Report Key: 4134661
• MDR Text Key: 4946306
• Report Number: 2024601-2014-00549
• 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: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LAP-BAND ADJUSTABLE GASTRIC BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2014
• 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: NUVARING; LEXAPRO
• Patient Age: 39 YR
• Patient Weight: 79