FDA Adverse Event Malfunction Summary report: N

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

MDR report key: 2240832 · Received August 16, 2011

Report

Report Number: 2024601-2011-00632
Event Type: Malfunction
Date Received: August 16, 2011
Date of Event: July 18, 2011
Report Date: July 20, 2011
Manufacturer: ALLERGAN
Product Code: LTI
PMA / PMN Number: P000008
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NO INFORMATION

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN EXPLANTED, AT THIS TIME, AND THEREFORE, WAS NOT RETURNED TO ALLERGAN. 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 UPON REMOVAL. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. 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

PT REPORTED AN ALLEGED LEAK, SPECIFICALLY A "HOLE," IN A LAP-BAND PORT. THE PT WENT FOR A CONSULTATION WITH THE SURGEON BECAUSE THE PT WAS NO LONGER "FEELING FULL." THE DOCTOR ASPIRATED THE BAND AND FOUND NO FLUID. THE SURGEON THEN PERFORMED AN X-RAY WHICH CONFIRMED A "HOLE IN THE PORT." F/U FINDINGS: EXPLANT SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. THE SURGEON'S STAFF WILL NOTIFY ALLERGAN PS IF EXPLANT OCCURS. THE DEVICE REMAINS IMPLANTED AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM		LTI	ALLERGAN	NA	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR