BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2140931 · Received June 21, 2011

    Report

    Report Number
    2024601-2011-00511
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    November 15, 2010
    Report Date
    May 23, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2011. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND 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, PAIN, AND AN ABSCESS ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND AN ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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. IN THE PRESENCE OF INFECTION OR CONTAMINATION, REMOVAL OF THE DEVICE IS INDICATED." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN 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, CHEST PAIN, INCISION PAIN, AND PORT SITE PAIN."

    Description of Event or Problem · 1

    A PT CALLED TO REPORT THAT ABOUT 4 WEEKS AFTER IMPLANT SURGERY THE PT BEGAN FEELING SICK, SO FOLLOW-UP WAS CONDUCTED WITH THE PHYSICIAN WHO DID NOT BELIEVE IT WAS RELATED TO THE SURGERY. AFTER SIX WEEKS, THE PT WAS RUSHED TO THE HOSPITAL. AFTER A CT SCAN WAS DONE, THE PT HAD EMERGENCY SURGERY TO REMOVE THE LAP-BAND DUE TO EXPERIENCE OF SEVERE PAIN, SEPSIS AND AN EXPLODED INTERNAL ABSCESS. PER THE PT THE PHYSICIAN SAID THE BAND WAS CONTAMINATED AND AN INTERNAL ABSCESS HAD EXPLODED. THE PT WAS RELEASED FROM THE HOSPITAL AFTER A WEEK STAY. AFTER REMOVAL, THE PT HAD TO HAVE A TEMPORARY HOLE IN THEIR ABDOMEN, SO THAT PUSS CAN BE DRAINED. ADDITIONAL DOCUMENTATION HAS BEEN PROVIDED THROUGH THE HOSPITAL AND ALLERGAN IS IN THE PROCESSING OF REVIEWING THE INFORMATION. ANY ADDITIONAL INFORMATION WILL BE FORWARDED TO THE FDA IN A SUPPLEMENTAL MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 2003364

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention NONE REPORTED