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

Catalog Number SAGBX

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that after the patient's initial implant it seemed to be ok.Their initial weight was (b)(6) and his lowest weight was (b)(6).The patient indicated that it doesn¿t matter how much the doctor puts into the device he can eat as much as he wants.The device would not limit his intake.His weight is currently (b)(6).He believes that this is a result of a low carbohydrate diet that he was on.He is back up to (b)(6).He went back to his doctor in the early stages after the device was implanted.He also noted that he was in for a different unrelated procedure and while he was there the physician tried to locate the port and attempted to fill it and it was difficult to find.Countless times the patient would have episodes of gagging and fluids would back up lasting from twenty minutes to an hour.The device was initially implanted in 2009 and he started noticing issues about a year and a half later.

Manufacturer Narrative

(b)(4).Additional information: weight still high at 275lbs.Still having all issues as before when complaint was opened.Going to schedule having fluid from my band hopefully in the next few weeks.Do not have info on product or band info at this time.Will ask when i visit for fluid removal.

• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8480583
• MDR Text Key: 140929895
• Report Number: 3005075853-2019-17786
• 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
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SAGBX
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 04/11/2019
• Supplement Dates FDA Received: 05/08/2019
• Patient Sequence Number: 1