BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLERGAN LAP-BAND

    MDR report key: 7776703 · Received August 13, 2018

    Report

    Report Number
    7776703
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    September 12, 2017
    Report Date
    July 31, 2018
    Manufacturer
    APOLLO ENDOSURGERY, INC
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD ADJUSTABLE GASTRIC BAND PLACED APPROX. NINE YEARS AGO. SHE HAS HAD SEVERAL ADJUSTMENTS DONE WITH THE LATEST APPROX. ONE YEAR AGO. NO DYSPHAGIA OR GERD. HAD HISTORY OF UNFILL DUE TO UGI SHOWING SLIP LAST YEAR WITH IMPROVEMENT NOTED. HOWEVER, THERE HAS BEEN DIFFICULTY IN ACCESSING THE PORT (CATHETER KINK VS. BAND LEAK). OPTIONS DISCUSSED BAND REMOVAL OR BAND REVISION. PROCEDURE DONE FIVE MONTHS AGO: LAPAROSCOPIC REVISION (REMOVAL AND REPLACEMENT) OF ADJUSTABLE GASTRIC BAND, RELOCATION OF PORT, HELLER MYOTOMY, EXCISION OF CICATRIX, TAKEDOWN OF FUNDOPLICATION, LYSIS OF ADHESIONS. PRE-OP DIAGNOSIS: GASTRIC BAND MALFUNCTION, OBESITY CLASS I, BMI 30-34.9. POST-OP DIAGNOSIS: SAME AS ABOVE, GASTRIC BAND SLIPPAGE. FINDINGS: LAP-BAND PORT WAS DISSECTED FROM THE SUBCUTANEOUS POCKET AND EXCISED OUT THRO THIS INCISION. THE CATHETER WAS FRACTURED 2 INCHES FROM THE PORT AND COMPLETELY DISCONNECTED. THE LAP-BAND WAS SEEN TO HAVE SLIPPED AND WAS MODERATE IN SIZE. THERE WAS A MODERATE-SIZED HERNIA SAC WHICH WAS EXCISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619976 ALLERGAN LAP-BAND IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI APOLLO ENDOSURGERY, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 14965 DA