BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 2151170 · Received June 21, 2011

    Report

    Report Number
    2024601-2011-00512
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 27, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE CATALOG NUMBER AND THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. FURTHER INFORMATION FROM THE REPORTER REGARDING THE SERIAL NUMBER OF THE DEVICE HAS BEEN REQUESTED. 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 VOMITING AS FOLLOWS: "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PATIENT EATS MORE THAN RECOMMENDED."

    Description of Event or Problem · 1

    ALLERGAN REPRESENTATIVE REPORTED AN ALLEGED "LEAKING PORT, PROBABLY A CRACK AT THE STRAIN RELIEF." THE DOCTOR TOOK THE PATIENT TO HAVE A FLUOROSCOPY DONE "AND NO LEAKAGE SHOWED UP." THE PATIENT ALSO REPORTED THE ALLEGED LEAK WITH THIS LAP-BAND DEVICE. THE PATIENT EXPERIENCED "LACK OF RESTRICTION" OVER THE LAST MONTH. THE PATIENT STATED THAT THE PHYSICIAN ASPIRATED THE BAND AND FOUND LESS FLUID THAN WAS PLACED AT THE TIME OF THE LAST FILL. THE PATIENT STATED THAT THE SURGEON "PERFORMED AN X-RAY TO CHECK FOR A LEAK, HOWEVER, THE RESULTS WERE INCONCLUSIVE." THE PATIENT STATED THAT "THE SURGEON STILL SUSPECTS AN ALLEGED LEAK." A FLUOROSCOPY WAS ALSO PERFORMED, BUT IT "DID NOT SHOW A LEAK." THE PATIENT STATED IT WAS SUPPOSED TO HAVE 8CC'S IN THE BAND, BUT EVERY TIME THE PATIENT GOES BACK TO THE DOCTOR THERE IS ONLY 2CC'S. THE DEVICE REMAINS IMPLANTED AT THIS TIME. FOLLOW-UP FINDINGS: THE PATIENT CAME BACK TO SEE THE SURGEON AFTER A YEAR SINCE THE LAST VISIT. THE PATIENT "HAD A VIRUS AND HAD VOMITED." AFTER THAT, THE PATIENT FELT "NO RESTRICTION" AND SO THE PATIENT CAME IN TO CHECK THE BAND. THE SURGEON SAW THAT THE PATIENT'S BAND "ONLY HAD 2.5 CC'S" AND IT WAS SUPPOSED TO HAVE "7CC'S" SO "3.5CC'S" WERE PUT IN. THE PATIENT CALLED THE NEXT DAY SAYING THEY COULDN'T FEEL ANY DIFFERENCE. THE PATIENT CAME IN AGAIN AND THE SURGEON FOUND ONLY 2.5CC'S. THE SURGEON INJECTED CONTRAST INTO THE BAND AND THE LEAK SHOWED UP THROUGH THE X-RAY. A FLUOROSCOPY WAS PERFORMED. AT A LATER CHECK-UP APPOINTMENT THE PATIENT HAD 2.5 CC'S AGAIN. THE SURGEON "SUSPECTS THAT IT WAS THE PORT THAT WAS LEAKING AND NOT THE BAND." EXPLANT SURGERY HAS BEEN SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR NONE REPORTED