BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 1091683 · Received August 1, 2008

    Report

    Report Number
    2024601-2008-00403
    Event Type
    Death
    Date Received
    August 1, 2008
    Date of Event
    June 20, 2008
    Report Date
    July 7, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER TYPE II. MEDWATCH SENT TO FDA ON: 08/01/08. THE PROD ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE RPTR, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. NO AUTOPSY REPORT IS AVAILABLE FROM THE SURGEON. IT REMAINS UNK IF AN AUTOPSY WAS PERFORMED, OR IF THE DEVICE WAS EXPLANTED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DEATH AS FOLLOWS: "LAPAROSCOPIC OR LAPAROTOMIC PLACEMENT OF THE LAP-BAND SYS IS MAJOR SURGERY AND DEATH CAN OCCUR."

    Description of Event or Problem · 1

    REPORTED BY AN ALLERGAN EMPLOYEE AS: "DEATH, WITH PT EXPIRING 2 DAYS AFTER LAP-BAND SURGERY". F/U WITH THE DR REVEALS: "THE PT HAD INTRA-ABDOMINAL BLEEDING POST OPERATIVE DAY 2. THE PT DID NOT HAVE A PULMONARY EMBOLISM, BOWEL PERFORATION, OR GASTRIC BLEEDING". THE AUTOPSY REPORT STATES HE HAD INTRA-ABDOMINAL BLEEDING." THE DR DID NOT SAY IF THIS EVENT WAS RELATED TO THE LAP-BAND SYS OR NOT, HE DECLINED TO ANSWER. THIS EVENT IS BEING REPORTED BECAUSE ALLERGAN'S APPROACH IS TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1532487

    Patients

    Seq Age Sex Outcome Treatment
    1 Death