FDA Adverse Event Malfunction Summary report: N

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

MDR report key: 2002457 · Received January 28, 2011

Report

Report Number: 2024601-2011-00014
Event Type: Malfunction
Date Received: January 28, 2011
Date of Event: April 3, 2008
Report Date: January 5, 2011
Manufacturer: ALLERGAN
Product Code: LTI
PMA / PMN Number: P000008
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: NO INFORMATION

Narratives

Additional Manufacturer Narrative · 1

TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2011. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

Description of Event or Problem · 1

PT REPORTED, "I HAVE BEEN HAVING PROBLEMS WITH MY BAND LEAKING FOR A LONG TIME." THE PT ADDED THAT "SEVERAL TIMES A YEAR, I HAVE HAD TO GET FILLS AND [THE DOCTOR HAS BEEN] UNABLE TO EXTRACT MUCH FLUID FROM THE PREVIOUS FILL. AS TIME HAS GONE ON THE FILLS WERE NOT LASTING VERY LONG. [THE DOCTOR] CHECKED AGAIN AND FROM ONE WEEK TO THE NEXT I LOST ABOUT 75% OF THE FLUID." ADDITIONAL INFO PROVIDED BY THE HEALTH PROFESSIONAL CONFIRMED A "POSSIBLE LEAK" AFTER "F/U VISITS AMOUNT OF SALINE FOUND WAS MINIMAL."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG		LTI	ALLERGAN	NA	1375402

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR			MULTIVITAMINS\| HYZAAR\| FEXOFENADINE HCL\| TRICOR\| DIPHENHYDRAMINE