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

Catalog Number SAGBX

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Urinary Tract Infection (2120)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Additionally, the lot/batch or serial number was not provided; therefore, the manufacturing records evaluation could not be performed.Attempts were made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were any tests performed to diagnose if there was any issue with your realize band (for example, was fluoroscopy, endoscopy, or culture performed)? has it been determined/ confirmed that the symptoms you experienced were directly related to the realize band and how was it determined? please describe.How were your medical issues treated? surgery? medication? non-surgery? or non-medical treatment? please describe.Were you following a regular diet and fitness program and still did not lose weight with the realize band implant? did you have any realize band adjustments or has your realize band port been accessed?.

Event Description

It was reported that the realize band was implanted early march for weight loss.Reporter said she went to a seminar and got all the information and instructions and started working out like kickboxing.Reporter said she did not lose any weight but did not gain any.The reporter said she got frustrated and went to see a bariatric doctor who emptied the fluid from the port that goes into band.Reporter said no matter how much she eats, she is constantly hungry.Also cannot keep food down especially meat.Which she needs her protein intake.She was also having acid reflex issues, bronchitis every other month and urinary tract infection.Finally, reporter went to the same doctor and asked the implant to be removed.Most of her symptoms have improved.She is currently having issues like vision problems, asthma, fatigue, weakness and hardly leaving her house and she gained about 12 pounds.

Manufacturer Narrative

(b)(4).Date sent: 7/16/2021.Additional information was requested and the following was obtained: what was the exact date of implant of your realize band? (b)(6) 2009.Were any tests performed to diagnose if there was any issue with your realize band (for example, was fluoroscopy, endoscopy, or culture performed)? no.Has it been determined/confirmed that the symptoms you experienced were directly related to the realize band and how was it determined? please describe.Patient came the conclusion that the lap band was the source of her issues.How were your medical issues treated? it was removed in (b)(6) of 2019.Surgery? removal.Medication? yes, her family doctor put her on thyroid medicine ¿levothyroxine¿ and asthma medicine, nausea, antiacid- ¿omeprazole¿, depression ¿trazodone¿.Non-surgery? see previous.Or non-medical treatment? please describe.Were you following a regular diet and fitness program and still did not lose weight with the realize band implant? yes absolutely.Did not lose one pound did you have any realize band adjustments or has your realize band port been accessed? yes the fist year.¿they made it tighter, and it did not help¿.After four years which was 2013 she went back to the doctor because she was having issue, so the doctor took all of the fluid out.No restriction except the band itself.Six more adjustments a total of ten and it got worst.Still not losing weight.She told the doctor that she could not eat and still did not lose weight and told the doctor to get it out of her.Was your realize band removed and if so, what was the date your realize band was removed? (b)(6) 2019.Note:¿ patient is still suffering with illness and she has a knot where the port was, and she force her into retirement because of all the issues she is having¿.

• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 12084884
• MDR Text Key: 262650201
• Report Number: 3005075853-2021-03632
• 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,other
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SAGBX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 07/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other