MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ REALIZE ADJ GASTRIC BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB22

Device Problem Filling Problem (1233)

Patient Problems Nausea (1970); Vomiting (2144); Surgical procedure, additional (2564)

Event Date 04/21/2014

Event Type  Injury  

Event Description

It was reported that realize band was implanted on (b)(6) 2010.She went home after the implant and was nauseated the next day.She went to the emergency room the next day for severe dry heaves and nausea.Zofran was administered iv overnight and then she was released.The patient had a total of four fills/adjustments before having the band removed and her maximum fill was 9cc.All fills/adjustments were performed by the nurse practitioner except the last one which was performed by the surgeon.The patient was not experiencing any symptoms related to the band.The surgeon had requested an upper gi approximately 3 weeks prior to the removal to be performed as a check and noted that the pouch was enlarged.All the saline was removed and fluoroscopy was performed with barium.During the test, it was noted the barium did not advance and the surgeon found the band was too tight.The band was surgically removed on (b)(6) 2014.The surgeon discussed performing a gastric sleeve, but the patient declined.The status of the device is unknown.

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.Information not available, device not returned for analysis should the information be provided later, a supplemental medwatch will be sent.

Manufacturer Narrative

(b)(4).

Event Description

Attending surgeon and ees medical director concluded that the pouch dilation experienced by the patient is a known risk that can result from patient overeating and other factors.It was also concluded that these factors are not related to any band defect.

• Brand Name: REALIZE ADJ GASTRIC BAND
• 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-2 400; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3956130
• MDR Text Key: 4563267
• Report Number: 3005992282-2014-00043
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2014

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: RLZB22
• Other Device ID Number: BATCH # UNK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2014
• Initial Date FDA Received: 07/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR