MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ REALIZE INJECTION PORT AND APP; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZPT2

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4): information asked for but unknown or not provided during initial contact.Should the information be provided later, a supplemental medwatch will be sent.

Event Description

It was reported that the band was implanted in (b)(6) 2011.(b)(6) 2011, upon healing and attempts to fill for first time, it was found to have flipped 180 degrees.Revision completed (b)(6), 2011, port was actually replaced.This was the only time the port was actually replaced.All other revisions utilized the same port.On (b)(6), 2015 had a fourth revision since (b)(6) 2011 implant.Between (b)(6), 2011, a fill was attempted once post-surgery.Sometimes successful, most times not.Last revision was (b)(6), 2015.Dr.Added 1cc on (b)(6).Restriction was insufficient.Seen on monday, (b)(6) for additional tightening; after a lot of difficulty, pa was able to add 1.5 cc.By the next day i was in significant discomfort, chest tight, unable to keep down any fluid without vomiting.Hoped it would ease up on its own but when it didn't, called the office on friday, (b)(6) asking to be seen.Dr.Unavailable, however pa and another dr.Attempted to reach port, after 8 attempts gave up.I was able to get sips of fluid down at this point so determined it was not an emergency, told if had significant symptoms of dehydration over the weekend, to come to hospital for iv fluids, otherwise i was to return monday (b)(6) to see dr.Seen on (b)(6), restriction had eased up slightly but still having significant chest discomfort.Dr.Unavailable so scheduled for interventional radiology tuesday (b)(6), so port could be pinpointed and fluid withdrawn.During that procedure it was confirmed port was flipped 180 degrees and revision will be required again.Now finally my chest is no longer hurting from pressure.Able to sip fluids and eat a small bite of food at a time.Have lost 17 lbs.Since (b)(6).Which isn't a bad thing but it cannot be adjusted at this point to add or subtract.Am unable to ingest 60 grams of protein a day as recommended.Surgery has not been scheduled at this time.

• Brand Name: REALIZE INJECTION PORT AND APP
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): OBTECH MEDICAL SARL_; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): OBTECH MEDICAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5270814
• MDR Text Key: 33294633
• Report Number: 3005992282-2015-00049
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2015

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 Expiration Date: 03/31/2016
• Device Catalogue Number: RLZPT2
• Device Lot Number: ZMFBB6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1