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

Catalog Number B-2240

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 01/15/2015

Event Type  malfunction  

Event Description

Pt reported they have "never been able to reach satiety [with their lap-band (r) system], they've maxed out the fluid in the band that they could put in it." the doctor feels the lap-band(r) is "unbuckled or broken in the back" and it's "in a c shape with all the fluid in it, and then drops back when it's not." the lap- band(r) system remains implanted at this time.

Manufacturer Narrative

Taper ii.The reporter of the complaint was asked to return the product for analysis if it is explanted in the future.The device was repositioned and remains implanted.Based upon the model number, serial number and 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, if it is explanted in the future.The surgery has not occurred, so allergan has not received the device nor performed analysis at this time.Device labeling addresses the possible outcome of an unbuckled band as follows: "the mfr of the lap-band ap (tm) adjustable gastric banding system has designed, tested and manufactured it to be reasonably fit for its intended use.However, the lap-band ap (tm) system is not a lifetime product and it may break or fail, in whole or in part, at any time after implantation and notwithstanding the absence of any defect.Causes of partial or complete failure include, without limitation, expected or unexpected bodily reactions to the presence and position of the implanted device, rare or atypical med complications, component failure and normal wear and tear.In addition, the lap-band ap(tm) system may be easily damaged by improper handling or use.".

• 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: krista alvarado ; 301 w. howard ln; ste 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4502623
• MDR Text Key: 5348793
• Report Number: 2024601-2015-00022
• 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: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2015
• Device Catalogue Number: B-2240
• Device Lot Number: 2455243
• Other Device ID Number: (01)10811955020183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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: 53 YR