MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number SAGBX

Device Problem Nonstandard Device (1420)

Patient Problems Abdominal Pain (1685); Vomiting (2144)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.As the device was not returned, an analysis investigation could not be performed.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

It was reported that the realize band placed in (b)(6) 2008.Patient indicated that she has been having issues for years since the device was placed.She went to the fda web site and found out that the device that was implanted was on a recall list.She intends to make an appointment with her doctor to have the device removed, but has not scheduled it yet.Patient indicated that she gets sick all of the time and it feels like the device has slipped since it was implanted.She has acid reflux indigestion.She takes ten tums a day sometimes more.When she is sleeping she will throw up and gasp for air and choke.This has occurred in the last year.She has nausea and vomiting all of the time.She also has a pulling sensation accompanied with pain in the general area of the port.Sometimes she can not stand up because of the pulling sensation.

Manufacturer Narrative

(b)(4).Date sent: 8/7/2020.Additional information received: per the patient, she confirmed this is a realize band and the band is still implanted.Patient does not know the exact band (straight or curved), how much fluid is in the band nor the maximum amount that had been in the band.Their last adjustment was 8 years ago.In their last appointment with the doctor everything looked fine with the band.They had been having issue with it being too tight, so her doctor took some of the fluid out.However, that was 8 years ago.They have not had any testing (endoscope, barium swallow, etc.).Lately, the patient has had consistent re-flux and has to sleep on her side and elevated.Per the patient, the issues are so severe now that they aspirate on stomach acid in their sleep at least five times a week waking up gasping for air and coughing up stomach acid from their lungs.The patient has not been seen by a doctor or had medical treatment concerning these issues due to it not being covered by her insurance.

Manufacturer Narrative

(b)(4).Date sent: 9/9/2020.Additional information: spoke with patient who indicated during her last appt approximately 9 years ago, they removed fluid from the band to reduce restriction.She has been successful in her weight loss over the years (approximately 90 lbs); however, she is concerned about the symptoms she currently experiences at night.

Manufacturer Narrative

(b)(4).Date sent: 9/16/2020.Dr.¿s office indicated that because the patient has not been seen in many years, the dr.Would like to order diagnostics and see the patient as they were not aware of the concerns.Spoke with patient today who indicated an upper gi has been scheduled for monday, (b)(6).Once that has occurred she will be scheduled to see the dr.

Manufacturer Narrative

(b)(4).Date sent: 10/26/2020.Additional information: spoke with patient who indicated that she has an appointment with dr.On november 5th and he plans to remove fluid at that time.He has reviewed the upper gi taken in sept and the patient indicated the radiologist noted ¿limited passage of contrast material through gastric band.¿ she continues to have difficulty swallowing.

• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8749339
• MDR Text Key: 149915523
• Report Number: 3005075853-2019-20174
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SAGBX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 07/28/2020; 08/17/2020; 09/16/2020; 10/26/2020
• Supplement Dates FDA Received: 08/07/2020; 09/09/2020; 09/16/2020; 10/26/2020
• Patient Sequence Number: 1