FDA Adverse Event Malfunction Summary report: N

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

MDR report key: 2894610 · Received December 27, 2012

Report

Report Number: 2024601-2012-01358
Event Type: Malfunction
Date Received: December 27, 2012
Date of Event: May 15, 2012
Report Date: December 6, 2012
Manufacturer: ALLERGAN
Product Code: LTI
PMA / PMN Number: P000008
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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 EXAM MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. 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

SURGEON REPORTED, LAP-BAND ACCESS PORT LEAKING, PLASTIC SEPTUM HOUSING SPLIT AROUND THE TOP EDGE, APPROXIMATELY 1 OR 2 MM INFERIOR TO THE SILICONE SEPTUM CAUSING A LEAK. F/U FINDINGS: PT SEEN SEVEN MONTHS PRIOR EXPLANTATION FOR FILL, TOTAL 2.5 ML, THREE MONTHS LATER, WEIGHT HAD GONE UP 4 KGS WITH ONLY 2 ML OF FLUID REMAINED. FOLLOWING THE PT TWO MONTHS LATER, THE PT HAD GAINED 2KGS MORE AND ONLY 0.25 ML OF FLUID REMAINED IN BAND.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM		LTI	ALLERGAN	NA	S02LB169

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR