MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAPBAND; IMPLANT, INTRAGASTRIC FOR MORBID

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Gastritis (1874); Inflammation (1932); Respiratory Distress (2045); Tachycardia (2095); Joint Swelling (2356); Neck Pain (2433); Palpitations (2467)

Event Date 06/30/2008

Event Type  Injury  

Event Description

I had a lap band implanted in (b)(6) (date unk) 2007.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 are told could be a heart attack.I had the band removed on (b)(6) 2018 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.I feel like i have been given a second chance at life since the removal.It is a torture device and i've no doubt my life was going to be shortened by having it inside my body.It was an inflammation nightmare.

• Brand Name: LAPBAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.
• MDR Report Key: 8032868
• MDR Text Key: 126236346
• Report Number: MW5081011
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 113