FDA Adverse Event Death Summary report: N

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

MDR report key: 584596 · Received March 21, 2005

Report

Report Number
2024601-2005-00124
Event Type
Death
Date Received
March 21, 2005
Date of Event
January 29, 2005
Report Date
February 19, 2005
Manufacturer
BIOENTERICS CORPORATION
Product Code
LTI
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

ONE OF THESE PTS FORWARDED THE INFORMATION: THIS REPORT WAS POSTED ON AN INTERNET FORUM BY ANOTHER PT WHO STATED THAT THEIR FRIEND WHO ALSO HAS A LAP-BAND WAS HAVING PROBLEMS. THEY RELAYTED THAT THE PT STARTED EXPERIENCING STRONG REFLUX/HEARTBURN AND WAS TAKING PEPCID BUT DID NOT CONTACT THE DOCTOR. THE PT WAS VOMININT VIOLENTLY FOR SEVERAL DAYS AND STILL DID NOT CONTACT THE DR. FINALLY THE PT WENT TO THE EMERGENCY ROOM AFTER VOMITING BLOOD. THEY DIAGNOSED GASTRITIS AND DISCHARGED THE PT HOME WITH A PRESCRIPTION. VOMITING CONTINUED AND THE PT WAS ADMITTED TO THE HOSP. ENDOSCOPY PERFORMED RESULTS NEGATIVE, GI TEST SUSPECTED ULCER, REUSLTS NEGATIVE. DAY FIVE OF HOSPITALIZATION, A DOCTOR REMOVED THE FLUID FROM THE BAND. THE PT FELT BETTER THE NEXT DAY. THEN THE PT GOT A FEVER AND HAD SEVERE ABDOMINAL PAIN. THE PT HAD A MASSIVE ABDOMINAL INFECTION AND WAS ON MORPHINE FOR THE PAIN. AN EMERGNECY PROCEDURE DONE TO REMOVE THE BAND. "THEY DID FIND A HOLE IN THE PT'S STOMACH AND REMOVED THE BAND ALONG WITH HALF OF THE STOMACH. REPORTER UNDERSTANDS IT WAS TOUCH AND GO AND THE PT COULD HAVE DIED". FURTHER FOLLOW-UP FINDINGS WITH THE PERSON WHO POSTED THIS PT EVENT NOTED THAT THE PT HAD DIED AND ONE OF THE SURGEONS ENVOVED IN THE PROCEUDRE TO REMOVE THE LAP-BAND HAS BEEN ASKED TO CONTACT INAMED. FOLLOW-UP WITH SURGEON WHO ASSISTED TO THIS SURGICAL CASE PROVIDED FURTHER CLARIFICATION OF THE EVENTS; "THIS WAS NOT A NEW BAND PT. THE PT HAD BEEN OBSTRUCTED FOR TWO TO THREE WEEKS PRIOR TO SURGERY BEING PERFORMED. ONCE IN SURGERY IT WAS FOUND THAT THE PT HAD GANGRENE OF THE STOMACH. THE PROXIMAL STOMACH HAD BEEN OCCLUDED, LOST THE BLOOD SUPPLY AND NECROSED CAUSING A PERFORMATION. THE BAND WAS INTACT BUT REMOVED AND DISCARDED SO THAT AN ANASTOMOSIS COULD BE PERFOMRED. THE PT RECOVERED FROM SURGERY AND WAS DISHCARGED FROM THE HOSPITAL. THE PT DIED APPROX ONE MONTH LATER AT HOME PRESUMABLY FROM A PULMONARY EMBOLISM". INAMED'S APOPROACH TO COMPLIANCE IS TO RESOLVE ALL DOUBLTS IN FAVOR OF REPORTING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM DEVICE FOR TREATMENT OF MORBID OBESITY LTI BIOENTERICS CORPORATION NA NI

Patients

Seq Age Sex Outcome Treatment
1 NO INFO Death