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

Catalog Number B-2240

Device Problems Fluid/Blood Leak (1250); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 07/30/2013

Event Type  Injury  

Event Description

Healthcare professional reported a "patient was seen in office for a painful [lap-band] port.Patient has lost 134+ pounds and port is beginning to protrude and needed repositioning.During surgery, [the doctor] tested port and blue dye showed back of port was leaking." the lap-band port was removed and replaced.

Manufacturer Narrative

Allergan has received the product however the device has not been identified nor has the analysis been completed at this time.Based upon the catalog number and implanted date provided by the reporter the connector type is assumed to be a taper ii.Pain and visibility are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the possible outcome of leakage as follows: "deflation of the band may occur due to leakage from the band, the port or the connector tubing." device labeling addresses the reported event of pain as follows: "there were additional occurrences of these events that were considered to be non-serious.Other adverse events considered related to the lap-band system that occurred in fewer than 1% of subjects included: abdominal pain, chest pain, incision pain and port site pain." device labeling addresses the possible outcome of visibility/palpability as follows: precautions: 6.Care must be taken to place the access port in a stable position away from areas that may be affected by significant weight loss, physical activity, or subsequent surgery.Failure to do so may result in the inability to perform percutaneous band adjustments.

• Brand Name: LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
• 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: 3720620
• MDR Text Key: 4267806
• Report Number: 2024601-2014-00129
• 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: 02/26/2014

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B-2240
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2014
• Initial Date FDA Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR