BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 2140908 · Received June 21, 2011

    Report

    Report Number
    2024601-2011-00478
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    February 25, 2011
    Report Date
    May 24, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    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. INFECTION AND PAIN ARE SURGICAL AND PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE OF THESE EVENTS. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER OF THE DEVICE DATE HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN INFECTION AS FOLLOWS: "INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD OR YEARS AFTER INSERTION OF THE DEVICE. IF THE PRESENCE OR INFECTION OR CONTAMINATION, REMOVAL OF THE DEVICE IS INDICATED." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AND DEHYDRATION AS FOLLOWS: "THERE WERE ADDITIONAL OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ...ABDOMINAL PAIN, DEHYDRATION, CHEST PAIN, INCISION PAIN, AND...PORT SITE PAIN."

    Description of Event or Problem · 1

    A PT IMPLANTED WITH A LAP-BAND DEVICE REPORTED EXPERIENCING ABDOMINAL PAIN AND A FEVER. PER THE PT, IT WAS LATER DETERMINED BY THE SURGEON THAT THE SYMPTOMS WERE CAUSED BY AN ALLEGED INFECTION. THE PT WAS HOSPITALIZED DUE TO THE INFECTION. A DOCTOR PERFORMED A (COMPUTERIZED TOMOGRAPHY) CT SCAN TO DIAGNOSE THE PROBLEM. THE PT WAS ADMINISTERED INTRAVENOUS ANTIBIOTICS IN THE HOSPITAL. THE BAND WAS REMOVED AND NOT REPLACED. FURTHER F/U WITH THE PHYSICIAN INDICATES THE OPERATIVE REPORT STATES, "...WENT HOME FINE, 10 DAYS AFTER IMPLANT SURGERY, [THE PATIENT] HAD A TEMP OF 102 AND MID EPIGASTRIC PAIN. THE PT WENT TO THE EMERGENCY ROOM. RADIOLOGISTS DID A CT SCAN." WHEN ASKED WHAT WAS THE SOURCE OF THE INFECTION, IT WAS INDICATED THAT THE OPERATIVE REPORT STATES, "THERE IS EITHER A SPLENULE VERSES A LEFT ADRENAL MASS IN THE UPPER QUADRANT." IT WAS UNK BY THE PHYSICIAN IF THE INFECTION WAS CULTURED OR WHAT THE CULTURE RESULTS WERE AS THE HOSPITAL HAS THAT INFO. FURTHER F/U WITH THE HOSPITAL NOTES THAT THEY WOULD NOT BE ABLE TO PROVIDE FURTHER INFO UNLESS THE PT GAVE CONSENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE REPORTED.