LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

Report

Report Number: 2024601-2011-00487
Event Type: Malfunction
Date Received: June 17, 2011
Date of Event: July 11, 2006
Report Date: May 24, 2011
Manufacturer: ALLERGAN
Product Code: LTI
PMA / PMN Number: P000008
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE 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 REPORTED EVENT OF PAIN AS FOLLOWS: "THERE WERE ADD'L OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYS THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED:...ABDOMINAL PAIN, DEHYDRATION, CHEST PAIN, INCISION PAIN, AND...PORT SITE PAIN." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DISPLACEMENT AS FOLLOWS: "CARE MUST BE TAKEN TO PLACE THE ACCESS PORT IN A STABLE POSITION AWAY FROM AREAS THAT MAY BE AFFECTED BY SIGNIFICANT WEIGHT LOSS, PHYSICAL ACTIVITY, OR SUBSEQUENT SURGERY," MIGRATION OF THE BAND AND/OR TIPPING TO THE ACCESS PORT CAN OCCUR, RESULTING IN REDUCED WEIGHT LOSS, WEIGHT GAIN OR OTHER COMPLICATIONS, AND POSSIBLE REOPERATION TO REMOVE OR REPOSITION THE DEVICE."

Description of Event or Problem · 1

HEALTH PROFESSIONAL REPORTED THAT THE LAP-BAND PORT WAS REMOVED AND REPLACED BECAUSE IT ALLEGEDLY "TURNED SIDEWAYS CAUSING PAIN AND THINNING OF THE SKIN OVER THE PORT."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)		LTI	ALLERGAN	NA	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	21 YR		Required Intervention