MAUDE Adverse Event Report: ALLERGAN / APOLLO ENDOSURGERY INC. GASTRIC BANDING DEVICE LAPBAND; IMPLANT INTRAGASTRIC FOR MORBID OBESITY

Device Problem Material Erosion (1214)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Visual Disturbances (2140); Weakness (2145); Burning Sensation (2146); Palpitations (2467); Abdominal Distention (2601)

Event Date 08/27/2007

Event Type  Injury  

Event Description

Lap band was implanted in (b)(6) 2007.Followed doctor's orders for years and lost weight.Only received one fill the entire life of the band.Beginning in 2014, i started having severe gastric issues-bloat, indigestion, severe pain, bowel inflammation and associated ailments.Pain worsened through the years and extended to my joints.Referred to several different doctors to determine pain.I received several test, treatments, medicines and procedures to discover the problem.In (b)(6) 2018, my quality of life had effected every area of my body, including being able to function as an active mother, wife, employee and human.Took myself to emergency room after realizing the pain was so bad, i didn't think i would live another day.Er doctor had discovered my lap band had eroded completely through my stomach and severe infection had set in.I had emergency surgery to remove it.Post-surgery, i have had numerous issues including re-hospitalization, infections, the inability to digest food without severe pain, the inability to pass through my intestines without severe pain and abdominal bowel movement, the inability to drink fluids without burning sensations through my esophagus, and severe weakness due to malnutrition.My diabetes has become difficult to control and i'm having associated nephropathy, situational blindness/vision impairments, and cardiac palpitations.The scar tissue and damage from the lap band has permanently scarred my life- physically and emotionally.

• Brand Name: GASTRIC BANDING DEVICE LAPBAND
• Type of Device: IMPLANT INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN / APOLLO ENDOSURGERY INC.
• MDR Report Key: 7929917
• MDR Text Key: 122785889
• Report Number: MW5080307
• 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: 09/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 48 YR
• Patient Weight: 68