MAUDE Adverse Event Report: ALLERGAN LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

Catalog Number LAP-BAND ADJUSTABLE GASTRIC BA

Device Problem Device Slipped (1584)

Patient Problems Erosion (1750); Dyspnea (1816); Fever (1858); Headache (1880); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Nausea (1970); Dizziness (2194); Hernia (2240); Regurgitation (2259); Sore Throat (2396); Chest Tightness/Pressure (2463); Weight Changes (2607)

Event Date 01/01/2013

Event Type  Injury  

Event Description

Patient reported that the lap-band system has 'dropped, fallen off the stomach and is not in the correct place" first noticed when the patient reported having the "flu" then developing issues with "acid reflux".The patient reported "skin rash" and "vomiting" after treatment with medication.The patient also reported "wasn't able to breathe, had squeezing in between the chest, symptoms of vertigo, temporarily lost voice, erosion of the esophagus, weight gain, and leg and ankle swelling".In addition the patient stated, "after implantation surgery experienced high blood pressure that required hospitalization".The lap-band system remains implanted and has not been removed or replaced.Physician reported patient to be seen to determine "feasibility of correcting stomach herniation".The events of band slip and hernia were confirmed by a healthcare professional.

Manufacturer Narrative

Taper ii.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 implant date and event 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.Band slippage, hypertension, gastric erosion, hernia, dyspnea, inflammation/irritation, chest tightening, reflux, dizziness, fever, nausea, headache, sore throat 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 model number, serial number, patient data for further event details.

• Brand Name: LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
• Manufacturer (Section D): ALLERGAN; la aurora de heredia; la aurora de heredia
• 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 78746-0000 ; 8555513123
• MDR Report Key: 4924185
• MDR Text Key: 15575317
• Report Number: 3006722112-2015-00213
• 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: Consumer,Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/23/2015

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 Catalogue Number: LAP-BAND ADJUSTABLE GASTRIC BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: HIGH BLOOD PRESSURE MEDICATION; NEXIUM 24
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR