BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1649801 · Received April 1, 2010

    Report

    Report Number
    2024601-2010-00211
    Event Type
    Death
    Date Received
    April 1, 2010
    Date of Event
    October 15, 2009
    Report Date
    March 2, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B) (4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, THE DATE OF THE EVENT, AND THE IMPLANT AND EXPLANT DATES. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. THE REPORTED EVENTS ARE SURGICAL AND PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER AND THE IMPLANT DATE HAS BEEN REQUESTED. ALLERGAN HAS ATTEMPTED MULTIPLE FOLLOW-UPS WITH THE SURGEON'S OFFICE TO OBTAIN MORE DETAILS ON THE REPORTED ALLEGED EVENT. WE REQUESTED AUTOPSY RESULTS, AS WELL AS THE OPERATIVE REPORTS, AND OTHER PERTINENT INFO THAT MAY ASSIST ALLERGAN IN THE INVESTIGATION OF THE REPORTED ALLEGED EVENTS. NO ADD'L INFO WAS RECEIVED BY ALLERGAN AT THIS TIME. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF DEATH AND SURGERY-RELATED OBSERVATION/COMPLICATION AS FOLLOWS: "LAPAROSCOPIC OR LAPAROTOMIC PLACEMENT OF THE LAP-BAND SYSTEM IS MAJOR SURGERY AND DEATH CAN OCCUR. PRECAUTIONS: IT IS THE RESPONSIBILITY OF THE SURGEON TO ADVISE THE PT OF THE KNOWN RISKS AND COMPLICATIONS ASSOCIATED WITH THE SURGICAL PROCEDURE AND IMPLANT."

    Description of Event or Problem · 1

    ALLERGAN REP REPORTED A DEATH ASSOCIATED WITH A LAP-BAND SYSTEM PT. THE EXACT DATE OF THE DEATH IS UNK AT THIS TIME AND ONLY MINIMAL INFO WAS AVAILABLE FROM THE INITIAL REPORTER, A STAFF MEMBER AT THE SURGEON'S OFFICE. PER THIS SOURCE, THE DEATH WAS NOT RELATED TO THE LAP-BAND SYSTEM BUT RATHER OCCURRED DURING TROCHAR PLACEMENT. AT THIS TIME, IT IS NOT CLEAR IF THE SURGICAL PROCEDURE WAS THE INITIAL DEVICE PLACEMENT OR A REPLACEMENT SURGERY. ALLERGAN HAS ATTEMPTED MULTIPLE FOLLOW UPS WITH THE SURGEON'S OFFICE TO OBTAIN MORE DETAILS ON THE REPORTED ALLEGED EVENT. WE HAVE NOT BEEN ABLE TO OBTAIN ANY FURTHER INFO AT THIS TIME. THIS EVENT IS BEING REPORTED BECAUSE ALLERGAN'S APPROACH TO COMPLIANCE IS TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    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 NI Death