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 Incompatibility (2682)

Patient Problems Pain (1994); Paralysis (1997)

Event Date 04/20/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had the realize band placed in 2010.Immediately after placement, they noticed something was wrong.They had trouble with it from the start.Constant pain, could not eat or drink anything, etc.After numerous doctors and test with diagnosis of multiple problems, they finally got it removed in 2016.The realize band damaged their vagus nerve causing paralysis of my stomach (gastroparesis).

• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8048285
• MDR Text Key: 126504617
• Report Number: 3005075853-2018-14240
• Device Sequence Number: 0
• Product Code: LTI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SAGBX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention