MAUDE Adverse Event Report: ALLERGAN LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE); IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number B-2245

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

Patient Problems Nausea (1970); Pain (1994); Weight Changes (2607)

Event Date 01/06/2015

Event Type  Injury  

Event Description

Healthcare professional reported that the lap-band system was "not working", the patient was not satisfied with their weight loss.The patient initially had pain and nausea.The lap-band system was explanted.

Manufacturer Narrative

Taper unknown.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 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.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Pain, nausea and unsatisfactory weight loss are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.No additional information has been reported to allergan regarding the diagnostic testing.

Manufacturer Narrative

Taper ii.Medwatch sent to fda on 07/20/2015.Visual examination of the returned device determined the access port tubing connector to be a taper ii.Analysis noted a striated opening at the band tubing consistent with surgical end cuts to remove the device analysis noted a striated opening in the shell/ring described as surgical damage analysis noted the port tubing was thinning described as "observed a brown color on port tubing.".

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer (Section G): COSTA RICA; 900 parkway global park zona franca
• Manufacturer Contact: laura leboeuf ; 1120 s capital of tx hwy; bldg 1, ste 300; austin, TX 78748 ; 8555513123
• MDR Report Key: 4697018
• MDR Text Key: 15898587
• Report Number: 3006722112-2015-00131
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020190
• UDI-Public: (01)10811955020190
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2012
• Device Catalogue Number: B-2245
• Device Lot Number: 1822527
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• 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: PROAIR HFA; RITALIN; CITALOPRAM HYDROBROMIDE; XANAX; KLONOPIN; PRILOSEC; COMPEZINE; ACCUNEB; ZOCOR; SYNTHROID; MIRALAX; TRICOR; NORCO; IAMO TRIGINE
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 86