MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Inflammation (1932); Swelling (2091); Neck Pain (2433); Palpitations (2467); Irregular Pulse (2469)

Event Date 06/30/2008

Event Type  Injury  

Manufacturer Narrative

Taper unknown.Medwatch sent to fda on 12/13/2018.These events were reported by the patient.To date, apollo has not been able to confirm the reported events with the patient's physician.Without device or device serial, the taper type is unknown.If returned, visual examination may determine the connecter type associated with this event.Review of the device labeling notes the following: precautions: it is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant.Patients must be seen regularly during periods of rapid weight loss for signs of malnutrition, anemia or other related complications.Adverse events it is important to discuss all possible complications and adverse events with your patient.Complications which may result from the use of this product include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the patient's degree of intolerance to any foreign object implanted in the body.Other adverse events considered related to the lap-band® system that occurred in fewer than 1% of subjects included: esophagitis, gastritis, hiatal hernia, pancreatitis, abdominal pain, hernia, incisional infection, infection, redundant skin, dehydration, gi perforation, diarrhea, abnormal stools, constipation, flatulence, dyspepsia, eructation, cardiospasm, hematemesis, asthenia, fever, chest pain, incision pain, contact dermatitis, abnormal healing, edema, paresthesia, dysmenorrhea, hypochromic anemia, band leak, cholecystitis, esophageal dysmotility, esophageal ulcer, esophagitis, port displacement, port site pain, spleen injury and wound infection.Warnings: patients should be advised that the lap-band ap® system is a long-term implant.Explant (removal) and replacement surgery may be indicated at any time.Medical management of adverse reactions may include explantation.Revision surgery for explantation and replacement may also be indicated to achieve patient satisfaction.

Event Description

Reported as: a patient reported "i had a lap-band implanted.I developed shortness of breath, heart palpitations, irregular heartbeat, inflammation around my upper stomach area, swollen ankles, swollen legs, swollen feet, constant burping, constant pain in my right shoulder that would run into my neck, constant pain in my right side and abdomen, a constant pain behind my left scapula that felt as if there were a growing tumor pushing under it.Many of the symptoms were similar to those we were told could be a heart attack.I had the band removed and my ankle swelling went away.My ankles/legs/feet/abdomen have not been swollen in over a month, and this is a miracle considering they started swelling when i got the band put in, and i have never gone this long without swelling.The band caused it.The pain that plagued me in my side, shoulder, chest, scapula and abdomen has completely gone away.My heart is beating regular again." the patient reported events has not been confirmed by a healthcare professional.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol of texas hwy; bldg 1, ste 300; austin TX 78746
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 8160688
• MDR Text Key: 130324782
• Report Number: 3006722112-2018-00318
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2018
• 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
• Patient Outcome(s): Required Intervention