MAUDE Adverse Event Report: ALLERGAN LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM ; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number B-2220

Device Problem Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 01/09/2014

Event Type  malfunction  

Event Description

Healthcare professional reported "the patient [noticed a] change in restriction from great restriction to no restriction.The physician identified "the ring of the band (pillow that holds the saline) herniated to the outer side of the outer shell of the band." the surgeon intends on removing and replacing the entire lap-band system.It is not known when the lap-band system will be explanted or replaced.

Manufacturer Narrative

The product associated with this report has not been returned as the device was not explanted.Based upon the model number and implant date provided by the reporter the connector type is assumed to be a taper ii.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.No additional information has been reported to allergan regarding the serial number.Device labeling instructs surgeons to prepare the lap-band system preparation: "view the inflatable portion of the band for weaknesses, leaks or uneven inflation.".

Manufacturer Narrative

Medwatch sent to fda on 07/17/2015.

Manufacturer Narrative

Medwatch sent to fda on 01/16/2015.Healthcare professional reported lap-band system was explanted.

Event Description

Healthcare professional reported lap-band system was explanted.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN; laaurora de heredia ; CS
• Manufacturer Contact: karen herrera ; 8555513123
• MDR Report Key: 3823307
• MDR Text Key: 16777330
• Report Number: 2024601-2014-00071
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020169
• UDI-Public: (01)10811955020169
• 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,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2006
• Device Catalogue Number: B-2220
• Device Lot Number: 622140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2014
• Date Manufacturer Received: 01/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR