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

Catalog Number B-2260

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); Regurgitation (2259)

Event Date 11/03/2013

Event Type  Injury  

Event Description

Healthcare professional reported "pt did well initially, but had unfilled for hysterectomy.Since that time the pt has been unable to get into green zone.Either too loose or too tight after small adjustments.Had lots of reflux after adjustments." the band is "either too loos or to tight after small adjustments and the pt "had lots of reflux after adjustments," the band is "either too loose or too tight after small adjustments and the pt "had lots of reflux after adjustments." first noticed when "we were unable to get back as much fluid as there should have been in band." the lap-band system was explanted and not replaced.Device will be returned.

Manufacturer Narrative

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.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYS (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 5506 ; CS 5506
• Manufacturer Contact: karen herrera ; 71 south los carneros road; goleta, CA 93117-5506 ; 8059615867
• MDR Report Key: 4256344
• MDR Text Key: 5045024
• Report Number: 2024601-2014-00604
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2011
• Device Catalogue Number: B-2260
• Device Lot Number: 1748976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2009
• 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: ATENELOL; ALTARE; SPIRONOLACTONE; PROZAC
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 88