BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEN (STANDARD)

    MDR report key: 2903758 · Received January 4, 2013

    Report

    Report Number
    2024601-2012-01365
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    October 17, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2012. ALLERGAN RECEIVED THE DEVICE; HOWEVER, THE ANALYSIS HAS NOT BEGUN AT THIS TIME. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. PAIN 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 OT LEAKAGE FROM THE BAND, 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 THAT WERE 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

    HEALTH PROFESSIONAL REPORTED A LAP-BAND PORT EXPLANT AND REPLACEMENT DUE TO A "POSSIBLE LEAK" AND PAIN. THE EVENT WAS FIRST NOTED WHEN PT NOTED "LESS RESTRICTION" AND PAIN AT THE PORT SITE. AFTER A FILL ADJUSTMENT, THE PHYSICIAN NOTICED THAT "LESS FLUID WAS REMOVED THEN THERE SHOULD HAVE BEEN." HEALTH PROFESSIONAL REPORTED "NO DIAGNOSTIC TESTING WAS PERFORMED" AS "THE DOCTOR BELIEVES THERE IS A LEAK AND STARTED WITH A PORT REPLACEMENT TO DETECT IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5139 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEN (STANDARD) LTI ALLERGAN NA 1819233

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention DEPO-PROVERA| BYETTA| BENICAR| ENDOCET| TOPROL| IMITREX