BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2347161 · Received November 18, 2011

    Report

    Report Number
    2024601-2011-01006
    Event Type
    Injury
    Date Received
    November 18, 2011
    Date of Event
    October 4, 2011
    Report Date
    October 25, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 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. FURTHER INFO FROM THE REPORTER REGARDING THE SERIAL NUMBER HAS BEEN REQUESTED. HERNIA, PAIN, REFLUX, INTOLERANCE, HEARTBURN, AND "BARRETT'S ESOPHAGUS" ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF HERNIA AS FOLLOWS: "THERE WERE ADD'L OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: HERNIAS, INCLUDING HIATAL HERNIAS. DEVICE LABELING ADDRESSES THE CONTRAINDICATION FOR PTS REGARDING INTOLERANCE AS FOLLOWS: "PTS WHO ARE KNOWN TO HAVE, OR SUSPECTED TO HAVE, AN ALLERGIC REACTION TO MATERIALS CONTAINED IN THE SYSTEM OR WHO HAVE EXHIBITED PAIN INTOLERANCE TO IMPLANTED DEVICES." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF REFLUX AND BARRETT'S ESOPHAGUS AS FOLLOWS: CAUTION: PTS WITH BARRETT'S ESOPHAGUS MAY HAVE PROBLEM ASSOCIATE WITH THEIR ESOPHAGEAL PATHOLOGY COULD COMPROMISE THEIR POST-SURGICAL COURSE. USE OF THE BAND IN THESE PTS SHOULD BE CONSIDERED ON THE BASIS OF EACH PT'S MEDICAL HISTORY AND SEVERITY OF SYMPTOMS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AS FOLLOWS: "THERE WERE ADD'L 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

    PT REPORTED ALLEGED "SEVERE HEARTBURN." THE PT ATTEMPTED TO RELIEVE THE SYMPTOM BY TAKING TUMS AND "STARTED TO HAVE THE HEARTBURN REGURGITATE INTO THE CHEST." THE PT ALSO NOTED "SUDDENLY AWAKEN IN A DEAD SLEEP, CHOKING FROM HEARTBURN." THE PT BEGAN EXPERIENCING "PAIN IN THE STOMACH AND CHEST AREA AFTER EATING. THE PT WAS TAKEN TO THE EMERGENCY ROOM. THE EMERGENCY ROOM DOCTOR "ORDERED AN EKC, CHEST X-RAY, ULTRASOUND OF THE ABDOMEN AND A URINALYSIS/BLOODWORK." ALL TESTING RESULTS WERE NORMAL WITH EXCEPTION TO THE ULTRASOUND WHICH SHOWED CALCIFICATION ON THE PT'S LIVER AND PORT. THE PT WAS PRESCRIBED "ANTACID MEDS" AND RELEASED. THE PT FOLLOWED UP WITH THEIR PRIMARY CARE PHYSICIAN WHO ORDERED A CT SCAN WHICH RESULTS CAME BACK NORMAL. THE PT ALSO FOLLOWED UP WITH THEIR BARIATRIC PHYSICIAN WHO ORDERED AN ENDOSCOPY, WHICH FOUND "BARRETT'S ESOPHAGUS" AND "HIATAL HERNIA. A BIOPSY WAS PERFORMED ON THE ESOPHAGUS, RESULTS PENDING.

    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 Hospitalization BIRTH CONTROL| CLARINEX-D| CYMBALTA| SINGULAIR| SYNTHROID