BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2210298 · Received August 9, 2011

    Report

    Report Number
    2024601-2011-00630
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 SURGEON HAS BEEN CONTACTED AND ASKED TO RETURN THE PRODUCT FOR ANALYSIS. IF IT WAS EXPLANTED. 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. A PULMONARY EMBOLISM AND DEATH ARE SURGICAL AND PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. PTS WITH SEVERE CARDIOPULMONARY DISEASES OR OTHER SERIOUS ORGANIC DISEASE ARE CONSIDERED POOR SURGICAL CANDIDATES. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR THE EXPLANT DATE. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DEATH 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 BECOMING AWARE OF A LAP-BAND PT'S DEATH. THE IMPLANT SURGERY HAD SUCCESSFULLY BEEN COMPLETED WITHOUT COMPLICATIONS AND THE PT WAS DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION. UNFORTUNATELY, APPROX FIVE DAYS LATER, THE PT RETURNED FROM A WORK DAY "NOT FEELING WELL" AND "GETTING WORSE" DURING THE EVENING. THE PT DIED THAT EVENING IN THE HOSPITAL. THE MEDICAL STAFF AT THE HOSPITAL MENTIONED THAT THE PT MAY HAVE EXPERIENCED A PULMONARY EMBOLISM (PE) AND DIED OF THE COMPLICATIONS 5 DAYS POST-OP. IT IS UNK, AT THIS TIME IF THE DEVICE WAS EXPLANTED AND IS AVAILABLE FOR RETURN TO ALLERGAN FOR PRODUCT ANALYSIS. F/U ATTEMPTS WITH THE SURGEON HAS NOT LEAD TO ANY NEW INFO AT THIS TIME.

    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