BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2192428 · Received July 26, 2011

    Report

    Report Number
    2024601-2011-00585
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE RPTR, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. PNEUMONIA, HERNIA, NAUSEA, PAIN, VOMIT AND COUGHING ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE OF THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF VOMIT AND NAUSEA AS FOLLOWS: "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PT EATS MORE THAN RECOMMENDED." "NAUSEA AND VOMITING MAY ALSO BE SYMPTOMS OF STOMA OBSTRUCTION OR A BAND/STOMACH SLIPPAGE. FREQUENT, SEVERE VOMITING CAN RESULT IN POUCH DILATATION, STOMACH SLIPPAGE OR ESOPHAGEAL DILATATION. DEFLATION OF THE BAND IS IMMEDIATELY INDICATED IN ALL OF THESE SITUATIONS. DEFLATION OF THE BAND MAY ALLEVIATE EXCESSIVELY RAPID WEIGHT LOSS AND NAUSEA AND VOMITING, OR RE-OPERATION TO REPOSITION OR REMOVE THE DEVICE MAY BE REQUIRED." "PT MUST BE CAUTIONED TO CHEW THEIR FOOD THOROUGHLY. PTS WITH DENTURES MUST BE CAUTIONED TO BE PARTICULARLY CAREFUL TO CUT THEIR FOOD INTO SMALL PIECES. FAILURE TO FOLLOW THESE PRECAUTIONS MAY RESULT IN VOMITING, STOMAL IRRITATION AND EDEMA, POSSIBLY EVEN OBSTRUCTION." 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." 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." "THERE WERE ADDITIONAL OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAB-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: INCISIONAL INFECTION, INFECTION, FEVER, ABNORMAL HEALING AND WOULD INFECTION." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF HERNIA AS FOLLOWS: "A LARGE HIATAL HERNIA MAY PREVENT ACCURATE POSITIONING OF THE DEVICE. PLACEMENT OF THE BAND SHOULD BE CONSIDERED ON A CASE-BY-CASE BASIS DEPENDING ON THE SEVERITY OF THE HERNIA." 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: HERNIAS, INCLUDING HIATAL HERNIAS.

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL REPORTED THAT A PT WAS ADMITTED TO THE HOSPITAL WITH NAUSEA, VOMITING, HERNIA AND PNEUMONIA. THE PHYSICIAN BELIEVES THAT THE PNEUMONIA MAY BE DEVICE RELATED. THE PT WAS ADMITTED TO HOSPITAL EMERGENCY ROOM THREE TIMES WITH VOMITING, REFLUX, PAIN, AND COUGHING OVER A SIX MONTH PERIOD. THE PHYSICIAN REMOVED 8CC OF FLUID ON THE LAST HOSPITALIZATION BELIEVING THE BAND WAS TOO TIGHT BUT SYMPTOMS DID NOT RESOLVE. THE DEVICE WAS REMOVED WITHOUT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1697196

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R