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

Catalog Number LAP-BAND ADJUSTABLE GASTRIC BA

Device Problem Material Deformation (2976)

Patient Problem Failure of Implant (1924)

Event Date 01/15/2013

Event Type  malfunction  

Event Description

Pt reported "the lap-band is not functioning and will not function anymore and needs to be replaced." pt reported they "noticed they were able to eat more." the pt reported that the healthcare professional tried to remove existing saline from the device but there was less fluid than the notes indicated.Pt stated that the physician noted that there was no leak of the band, but found a bulge in the band.The pt also reported that they have walking pneumonia that is not caused or related to the lap-band.The device remains implanted.Follow up findings: pt called in to report that device has been explanted.Events were then confirmed by explanting physician.

Manufacturer Narrative

The reporter of the complaint was asked to return the product analysis.The device has not yet been received by allergan.Based upon the partial 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.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): UNK ALLERGAN; 900 pakrway global park zona franca; la aurora de heredia ; CS
• Manufacturer Contact: krista alvarado ; 301 w howard lane; ste 100; austin, TX 78753-5506 ; 5128132638
• MDR Report Key: 4380441
• MDR Text Key: 5239565
• Report Number: 2024601-2014-00706
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• 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?: No
• Date Manufacturer Received: 12/18/2014
• 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: TOPAMAX; PHENTERMINE
• Patient Age: 37 YR
• Patient Weight: 156