BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1950240 · Received December 13, 2010

    Report

    Report Number
    2024601-2010-00970
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    October 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED AS THE DEVICE WAS NOT EXPLANTED. THE REPORTER OF THE COMPLAINT WAS ASKED TO INDICATE THE PRODUCT SERIAL NUMBER. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER WAS GIVEN. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. 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 (B)(4) OF SUBJECTS INCLUDED: ABDOMINAL PAIN, DEHYDRATION, CHEST PAIN, INCISION PAIN, AND PORT SITE PAIN." DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF INADEQUATE WEIGHT LOSS AS FOLLOWS: "SEVENTY-FIVE SUBJECTS HAD THEIR ENTIRE LAP-BAND SYSTEM EXPLANTED. (B)(4). (RECORDED AS OF (B)(6) 2000, CLINICAL STUDY, 299 PTS TOTAL)."

    Description of Event or Problem · 1

    PT REPORTED THAT THEY HEARD "SOMETHING POP" IN THEIR STOMACH AND WAS INFORMED THAT THEIR "CATHETER BROKE IN HALF" CAUSING PAIN. THE PT ALSO NOTED THAT THERE WAS A FEELING OF HUNGER AND THAT MAYBE THE BAND WAS NOT PLACED PROPERLY. THE DEVICE HAS NOT BEEN EXPLANTED. FURTHER FOLLOW-UP WITH THE HEALTH PROFESSIONAL NOTED THAT A FLUOROSCOPY WAS CONDUCTED WHICH CONFIRMED THE DISCONNECT OF THE TUBING. THE HEALTH PROFESSIONAL ALSO SAID THE PT CALLED AND INFORMED THEM THAT SINCE THE ADVERSE EVENT OCCURRED, WEIGHT HAS GONE BACK UP. REVISION SURGERY WAS DONE WITH A REPAIR KIT TO RECONNECT THE TUBING FROM THE PORT TO THE BAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention