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

Catalog Number LAP-BAND ADJUSTABLE GASTRIC BA

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/18/2013

Event Type  malfunction  

Event Description

Company representative reported a lap-band port "crack in the strain release of tubing" first noticed when the pt reported "no restriction, weight gain, and decreased satiety." the lap-band port was removed and replaced.

Manufacturer Narrative

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 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.The reporter of the event was asked to return the product for analysis.Allergan has not received the product at this time.Therefore, no analysis or testing has been done.No add'l info has been reported to allergan regarding the serial number.Device labeling addressed the possible outcome of leakage as follows: "deflation of the band may occur due to leakage from the band, the port of the connector tubing." inadequate weight loss is addressed in the labeling.Allergan does not guarantee that every pt will achieve desired weight loss.Device labeling addresses the possible outcome of inadequate weight loss as follows: "seventy-five subjects had the entire lap-band system explanted.Insufficient weight loss was also reported as a contributor ro the decision to explant in 24 of the 75 explants(32%).(recorded as of (b)(6) 2000, clinical study, 299 patients total).".

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; goleta CA
• Manufacturer (Section G): UNKNOWN ALLERGAN; 71 south los carneros road; goleta CA 93111
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615405
• MDR Report Key: 3772181
• MDR Text Key: 4377680
• Report Number: 2024601-2013-01058
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/09/2013
• Initial Date FDA Received: 01/02/2014
• 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
• Patient Age: 39 YR
• Patient Weight: 109