BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAP LRG W/RAPIDPORT EZ

    MDR report key: 3054481 · Received April 9, 2013

    Report

    Report Number
    2024601-2013-00232
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    August 15, 2012
    Report Date
    February 22, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE CATALOG NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. WOUND DEHISCENCE, WOUND DRAINAGE, AND ERYTHEMA 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 WOUND DRAINAGE 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. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF WOUND DEHISCENCE AS FOLLOWS: "ADVERSE EVENTS: PERFORATION OF THE STOMACH CAN OCCUR. DEATH CAN ALSO OCCUR. SPECIFIC COMPLICATIONS OF LAPAROSCOPIC SURGERY CAN INCLUDE SPLEEN DAMAGE (SOMETIMES REQUIRING SPLENECTOMY) OR LIVER DAMAGE, BLEEDING FROM MAJOR BLOOD VESSELS, LUNG PROBLEMS, THROMBOSIS, AND RUPTURE OF THE WOUND." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF ERYTHEMA AS FOLLOWS: OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 2% OF STUDY PATIENTS INCLUDED: DIARRHEA (N=2), GASTRIC POUCH DILATATION (N=2), GASTRITIS (N=2), ESOPHAGEAL DILATATION (N=2), SYNCOPE (N=2), SEROMA (N=2). OTHER EVENTS REPORTED TO OCCUR IN ONLY ONE PATIENT PER EVENT INCLUDED; ABDOMINAL DISCOMFORT, ALOPECIA, ANEMIA, ARTHRALGIA, DECREASE BLOOD FOLATE, FLATULENCE, GASTROINTESTINAL MOTILITY DISORDER, BRONCHITIS, CHILLS, IMPLANT SITE INFECTION, IMPLANT SITE IRRITATION, IMPLANT SITE HEMORRHAGE, NIGHT SWEATS, HYPOTRICHOSIS, HEADACHE, NAIL INFECTION, PYREXIA, SKIN IRRITATION, ESOPHAGEAL OBSTRUCTION, ESOPHAGEAL SPASM, POSTOPERATIVE INFECTION, URINARY TRACT INFECTION, MUSCLE SPASMS, DEPRESSION, BACK PAIN, AND HYPERTENSION.

    Description of Event or Problem · 1

    COMPANY REPRESENTATIVE REPORTED A LAP-BAND SYSTEM WAS EXPLANTED. NO ADDITIONAL INFORMATION. FOLLOW-UP INFORMATION: HEALTH PROFESSIONAL REPORTED THAT THE ORIGINAL PORT HAD BEEN EXPLANTED AND REPLACED ON AN EARLIER DATE "DUE TO SPONTANEOUS OPENING OF THE RIGHT UPPER QUADRANT PORT WOUND." THE BAND HAD REMAINED IMPLANTED. HEALTH PROFESSIONAL ADDED THAT A REMOVAL OF THE BAND PORTION WAS DONE RECENTLY DUE TO "SPONTANEOUS DRAINAGE OF SEROUS FLUID AND ERYTHEMA AROUND THE PORT. CULTURES WERE NEGATIVE, BUT THE WOUND FAILS TO HEAL APPROPRIATELY." "NONHEALING LAP-BAND PORT WOUND." THIS MEDWATCH 3500A FORM IS DOCUMENTING THE ORIGINAL BAND AND ORIGINAL PORT. MEDWATCH REPORT # 2024601-2013-00233 WAS OPENED TO REPORT THE NEW PORT - THAT WAS IMPLANTED DURING REMOVAL OF THE ORIGINAL PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147818 EAP LRG W/RAPIDPORT EZ LTI ALLERGAN NA 2221918

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention LEVOTHYROID| NOVOLOG FLEXPEN| CARDURA| LOVAZA| NEXIUM| CALCIUM CARBONATE| DIOVAN| LEXAPRO| ADVAIR DISKUS| VITAMIN B COMPLEX NO-12 NIACIN| VITAMIN D-12| LYRICA| ACTOS| TOPRO XL| LIVALO| ZYLOPRIM| ERGOCALCIFEROL