MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Achalasia (1692); Anemia (1706); Dysphagia/ Odynophagia (1815); Fatigue (1849); Pyrosis/Heartburn (1883); Vomiting (2144); Choking (2464); Constipation (3274); Aspiration Pneumonitis (4455); Wheezing (4463)

Event Date 03/01/2019

Event Type  Injury  

Event Description

Had gastric lap band placed in 2013.Developed severe gero/reflux starting in 2018.Issues persisted and got worse.Developed achalasia and my esophagus became severely dilated.I would wake up at night choking to the point i would vomit.I could only tolerate approximately 5 solid foods otherwise my diet was purely liquid.Starting in mid 2019 i stopped even being able to digest and swallow the 5 solid foods i was once able to tolerate.I went to numerous specialist, attempted to have an endoscopy done several times but the doctor was not able to advance scope down my throat due to the torturous condition of my esophagus and the severe achalasia and dilation.I went and saw a thoracic surgeon, three gastro doctors and 3 bariatric physicians.My insurance refused to cover the removal of the band.I developed aspiration pneumonia twice and even after remove i continue to not be able to lie down flat in bed.I was wheezing constantly.I developed severe anemia, all my numbers for my vitamin d, b-12 and hemoglobin were in single digits for the last year.I still suffer from fatigue.I was told by doctor i may end up on feeding tube rest of my life if the band didn't come out.The band caused severe complications with constipation.The last two months before i had the band removed there were days that i ate nothing because even liquids wouldn't go down.I vomited every day of my life for the last two years before my band was removed.I suffered from malnutrition due to the band.Fda safety report id# (b)(4).Had gastric lap band placed in 2013.Developed severe gero/reflux starting in 2018.Issues persisted and got worse.Developed achalasia and my esophagus became severely dilated.I would wake up at night choking to the point i would vomit.I could only tolerate approximately 5 solid foods otherwise my diet was purely liquid.Starting in mid 2019 i stopped even being able to digest and swallow the 5 solid foods i was once able to tolerate.I went to numerous specialist, attempted to have an endoscopy done several times but the doctor was not able to advance scope down my throat due to the torturous condition of my esophagus and the severe achalasia and dilation.I went and saw a thoracic surgeon, three gastro doctors and 3 bariatric physicians.My insurance refused to cover the removal of the band.I developed aspiration pneumonia twice and even after remove i continue to not be able to lie down flat in bed.I was wheezing constantly.I developed severe anemia, all my numbers for my vitamin d, b-12 and hemoglobin were in single digits for the last year.I still suffer from fatigue.I was told by doctor i may end up on feeding tube rest of my life if the band didn't come out.The band caused severe complications with constipation.The last two months before i had the band removed there were days that i ate nothing because even liquids wouldn't go down.I vomited every day of my life for the last two years before my band was removed.I suffered from malnutrition due to the band.Fda safety report id# (b)(4).Concomittant medical: advil, tylenol.

• Brand Name: LAP BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer (Section G): APOLLO ENDOSURGERY; building b 13.3; alajuelaike, ; CS
• Manufacturer Contact: brian stowe ; 1001 calle amanecer; san clemente, CA 92673 ; 9494817801
• MDR Report Key: 11390934
• MDR Text Key: 233963871
• Report Number: 3013508647-2020-00043
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2021
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2020
• 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