BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 3233920 · Received July 16, 2013

    Report

    Report Number
    2024601-2013-00616
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    November 15, 2012
    Report Date
    June 25, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4). THE DEVICE ASSOCIATED WITH THIS REPORT WAS DISCARDED AFTER SURGERY. BASED UPON THE CATALOG NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. INFECTIONS, PNEUMOTHORAX, LIVER ABSCESS, FEVER, WEAKNESS, NAUSEA, WEIGHT FLUCTUATION, AND BLOATING 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 INFECTION, ABSCESS, WEAKNESS, AND FEVER 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: ESOPHAGITIS, GASTRITIS, HIATAL HERNIA, PANCREATITIS, ABDOMINAL PAIN, HERNIA, INCISIONAL INFECTION, INFECTION, REDUNDANT SKIN, DEHYDRATION, GI PERFORATION, DIARRHEA, ABNORMAL STOOLS, CONSTIPATION, FLATULENCE, DYSPEPSIA, ERUCTATION, CARDIOSPASM, HEMATEMESIS, ASTHENIA, FEVER, CHEST PAIN, INCISION PAIN CONTACT DERMATITIS, ABNORMAL HEALING, EDEMA, PARESTHESIA, DYSMENORRHEA, HYPOCHROMIC ANEMIA, BAND LEAK, CHOLECYSTITIS, ESOPHAGEAL DYSMOTILITY, ESOPHAGEAL ULCER, ESOPHAGITIS, PORT DIS-PLACEMENT, PORT SITE PAIN, SPLEEN INJURY, AND WOUND INFECTION. "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 NAUSEA AND RAPID WEIGHT LOSS AS FOLLOWS: "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." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF BLOATING AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES."

    Description of Event or Problem · 1

    PATIENT REPORTED "AT FIRST, THE WEIGHT LOSS WAS GOING OKAY." ABOUT ONE MONTH AFTER IMPLANT SURGERY, PATIENT WAS "NOTICING A LOT OF BLOATING AND NAUSEA." PATIENT STATED THE PHYSICIAN FELT THE BAND "MAY HAVE BEEN TOO TIGHT," SO THE PHYSICIAN ADJUSTED THE BAND. PATIENT WAS "STILL EXPERIENCING NAUSEA." PATIENT "LOST 10-15 POUNDS VERY FAST, AND [BECAME] VERY WEAK." ABOUT THREE MONTHS LATER, PATIENT "BECAME VERY ILL." PATIENT WENT TO THEIR GENERAL PRACTIONER'S OFFICE "FOR AN EAR INFECTION" AND WAS PRESCRIBED ANTIBIOTICS, BUT "THE ANTIBIOTICS [WERE NOT] WORKING" AND PATIENT BEGAN EXPERIENCING "103-104 DEGREE FEVER." PATIENT STATED HAVING A "SEVERE BLOOD INFECTION THROUGHOUT THE BODY AND A HEPATIC LIVER ABSCESS THAT COVERED THE WHOLE LIVER." PATIENT ADDED THEIR "LUNGS HAD ALSO COLLAPSED." PATIENT WAS TREATED WITH ANTIBIOTICS AND "DRAINAGE TUBES WERE PUT THROUGH THE LIVER." THE ANTIBIOTICS WERE UNSUCCESSFUL AND "INFECTION HAD GOTTEN AROUND THE WHOLE LAP-BAND." DEVICE WAS REMOVED AND PATIENT STAYED IN THE "HOSPITAL FOR 23 DAYS." FOLLOW-UP INFORMATION: HEALTH PROFESSIONAL REPORTED THE PHYSICIAN FELT ALL SYMPTOMS WERE RELATED TO THE DEVICE AND "THAT IS WHY IT WAS EXPLANTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328297 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 2246372

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R HIGH BLOOD PRESSURE MEDICATION| EFFEXOR| SYNTHROID