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

Catalog Number B-2245

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/03/2014

Event Type  malfunction  

Event Description

Healthcare professional reported a patient had a lap-band system leak.The patient "initially had reasonable success with weight loss.However, the band has become nonfunctional and [the] weight is steadily increasing.The lap-band system was removed without replacement.Additional information: health professional said the patient had the gastric sleeve after removal of the system.

Manufacturer Narrative

Taper ii.The access port connector associated with this report has not been returned.Based upon the catalog number, serial number and implant date provided by the reporter the connector type is assumed to be a taper ii.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia ; CS
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117 ; 8059615867
• MDR Report Key: 3980472
• MDR Text Key: 4637834
• Report Number: 2024601-2014-00313
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2011
• Device Catalogue Number: B-2245
• Device Lot Number: 1762523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• 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: LISINOPRIL; NABUMETONE; EFFEXOR-XR; LYRICA; METFORMIN; LASIX; ZOCOR; PLAQUENIL
• Patient Age: 46 YR
• Patient Weight: 176