BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2932522 · Received January 23, 2013

    Report

    Report Number
    2024601-2012-01400
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    November 23, 2011
    Report Date
    December 11, 2012
    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

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4)2013. 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 REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OR MODEL NUMBER. INTOLERANCE AND VOMITING 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 EVENTS OF SURGICAL COMPLICATIONS AS FOLLOWS: "COMPLICATIONS WHICH MAY RESULT FROM THE USE OF THIS PRODUCT INCLUDE THE RISKS ASSOCIATED WITH THE MEDICATIONS AND METHODS UTILIZED IN THE SURGICAL PROCEDURE, THE RISKS ASSOCIATED WITH ANY SURGICAL PROCEDURE AND THE PT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY." DEVICE LABELING ADDRESSES THE POSSIBLE REPORTED EVENT OF VOMITING AS FOLLOWS: "FLUID SHOULD BE REMOVED FROM THE SYSTEM IF THERE WERE SYMPTOMS OF EXCESSIVE RESTRICTION OR OBSTRUCTION, INCLUDING EXCESSIVE SENSE OF FULLNESS, HEARTBURN, REGURGITATION AND VOMITING. IF SYMPTOMS ARE NOT RELIEVED BY REMOVAL OF THE FLUID, A BARIUM MEAL SHOULD BE USED TO EVALUATE THE ANATOMY."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A LAP-BAND SYSTEM EXPLANT DUE TO PT INTOLERANCE AND "EXCESSIVE VOMITING." THE PT EXPERIENCED "VOMITING EVEN AFTER HAVING THE BAND EMPTIED." FURTHER INFO RECEIVED NOTED THE DEVICE WAS EXPLANTED WITHOUT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33271 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1839489

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention ACETAMINOPHEN| ALBUTEROLE| HYDROCODONE| VALIUM| FLONASE| NYSTOP| LUNESTA| NABUMETONE| SERTRALINE| ROPINIROLE| LAMOTRIGINE| AMIROL| DIOVAN| DIAZEPAM| SPIRIVA| PROAIR| VITAMIN D TABLETS| BUSPAR| IBUPROFEN| IMODIUM| METHYLPHENIDATE| AMLODIPINE| CIPROFLOXACIN| BENZONATATE