MAUDE Adverse Event Report: APOLLO ENDOSURGERY LAP BAND SYSTEM

Device Problem Material Erosion (1214)

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Neuropathy (1983); Pain (1994); Paralysis (1997); Thrombus (2101); Anxiety (2328); Disability (2371); Weight Changes (2607); No Code Available (3191)

Event Date 02/15/2012

Event Type  Injury  

Event Description

Allergan lap band system failed - full erosion into stomach in (b)(6) 2012.It was immediately removed.Since that time, i have serious health issue, relating to the event and it has caused permanent disability.No doctor, no specialists can even observe or tell what is all going on inside the body since event.Problems with nerve, muscles, breathing, hormone fluctuations, low-mobility paralysis or neuropathy or abdomen area, blood clots in leg leading to pulmonary emboli (probably due to low-mobility), pain, stress, weight gain, and ongoing chronic overall condition.I feel that allergan did not do enough research prior to fast-tracking device with fda.Additionally, tax payers are paying for all the medical costs instead of allergan since they are protected by the supreme court under a legal theory called "federal preemption." the list of conditions i am experiencing as some are listed above, and i was screened knowing my history, but the labeling does not exclude me.This should also be looked into and since it may be harming other individuals with history of autoimmune dysfunction.Ref# mw5067140.

• Brand Name: LAP BAND SYSTEM
• Type of Device: LAP BAND SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY
• MDR Report Key: 6293609
• MDR Text Key: 66352461
• Report Number: MW5067586
• Device Sequence Number: 1
• Product Code: LTI
• 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: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 52 YR
• Patient Weight: 168