FDA Adverse Event Malfunction Summary report: N

REALIZE ADJ GASTRIC BAND STR

MDR report key: 1964068 · Received January 19, 2011

Report

Report Number: 3005992282-2011-00020
Event Type: Malfunction
Date Received: January 19, 2011
Date of Event: December 21, 2010
Report Date: December 30, 2010
Manufacturer: OBTECH MEDICAL SARL_
Product Code: LTI
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). BALLOON CUT IN TWO PARTS THE BALLOON/BAND WAS RETURNED IN TWO PARTS. THE COMPLAINT CANNOT BE CONFIRMED, DEVICE RETURNED FOR EVALUATION WAS DAMAGED AND IT WAS NOT POSSIBLE TO LOCALIZE THE LEAK UNDER VISUAL INSPECTION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BAND/BALLOON RETURNED FOR INVESTIGATION AND FINAL PACKAGING LOT, AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS IN RELATION TO THE ALLEGED ISSUE. IT WAS ALSO NOTED THAT 100% OF ALL DEVICES ARE LEAK TESTED PRIOR TO LOT RELEASE; THEREFORE IT IS UNLIKELY THAT MANUFACTURE PROCESS CONTRIBUTE AT THIS EVENT DESCRIPTION.

Additional Manufacturer Narrative · 1

(B)(4): INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

Description of Event or Problem · 1

IT WAS REPORTED BY THE PATIENT THAT A POST IMPLANT OF A REALIZE ADJUSTABLE BAND, THE BAND WAS LEAKING. THE PATIENT REPORTS HAVING 3-4 FILLS WITH AN UNKNOWN AMOUNT AND DID NOT HAVE RESTRICTION. THE PATIENT REPORTS CHANGING DOCTORS IN (B)(6) 2010 AND HAD ADDITIONAL 5 FILLS PERFORMED WITH UNKNOWN AMOUNTS. THE NEW DOCTOR TOOK AN X-RAY AND A LEAK WAS IDENTIFIED. THE BAND WAS REMOVED. THE PATIENT STATES SHE IS DOING WELL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	REALIZE ADJ GASTRIC BAND STR	IMPLANT, INTRAGASTRIC FOR MORBID OBESITY	LTI	OBTECH MEDICAL SARL_	UNK	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1