BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 1911056 · Received November 24, 2010

    Report

    Report Number
    2024601-2010-00920
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. 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. MYOCARDIAL INFARCTION IS A SURGICAL AND PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF MYOCARDIAL INFARCTION AND SURGICAL COMPLICATIONS AS FOLLOWS: "OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: "CARDIOSPASM, CHEST PAIN, ABNORMAL HEALING, EDEMA, HYPOCHROMIC ANEMIA, SPLEEN INJURY AND WOUND INFECTION. SPECIFIC COMPLICATIONS OF LAPAROSCOPIC SURGERY CAN INCLUDE SPLEEN DAMAGE (SOMETIMES REQUIRING SPLENECTOMY) OR LIVER DAMAGE, BLEEDING FROM MAJOR BLOOD VESSELS, LUNG PROBLEMS, THROMBOSIS, AND RUPTURE OF THE WOUND. 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 VIA EMAIL THAT A PT HAD A MYOCARDIAL INFARCTION POST-OPERATIVE. THE LAP-BAND REPLACEMENT PROCEDURE HAD BEEN COMPLETED AND THE MYOCARDIAL INFARCTION OCCURRED IN THE RECOVERY ROOM. ALLERGAN MEDICAL IS NOT REPORTING THIS EVENT BECAUSE OF A PRODUCT PROBLEM BUT POSSIBLE SURGICAL COMPLICATIONS. THE FOLLOW-UP IS IN PROGRESS AT THIS TIME AND NEW INFO WILL BE FORWARDED TO THE FDA IN A SUPPLEMENTAL MEDWATCH REPORT, UPON RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| L| R