BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM ACCESS PORT I KIT

    MDR report key: 3121868 · Received May 15, 2013

    Report

    Report Number
    2024601-2013-00383
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    October 18, 2012
    Report Date
    April 22, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2013. THE REPORTER INDICATED THAT THE DEVICE WILL NOT BE RETURNED AND HAD NO FURTHER INFO ON THE LOCATION OF THE DEVICE. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. INFECTION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING." 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: 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 DISPLACEMENT, PORT SITE PAIN, SPLEEN INJURY AND WOUND INFECTIONS."

    Description of Event or Problem · 1

    PT REPORT A LAP-BAND PORT LEAK. PT STATED THEY NOTICED THE "LEAK" WHEN THEY WERE ABLE "TO EAT MORE." PT REPORTED BEING "PRESCRIBED ANTIBIOTICS" ABOUT A YEAR AFTER THE PORT WAS IMPLANTED. HEALTHCARE PROFESSIONAL REPORTED THEY HAVE NO INFO REGARDING THE PT REPORT OF BEING PRESCRIBED ANTIBIOTICS. THE PHYSICIAN CONFIRMED THERE WAS A PORT LEAK. THE PORT WAS EXPLANTED AND REPLACED DUE TO A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215011 LAP-BAND SYSTEM ACCESS PORT I KIT LTI ALLERGAN NA 1513239

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention LISINOPRIL